ClinicalTrials.gg
Not yet recruitingNCT07812792Updated Oct 5, 2026

Effect of Pentadecanoic Acid Supplementation on Red Blood Cell Health and Biological Aging in Healthy Older Adults

A Phase 2 interventional study of Pentadecanoic Acid and Placebo in Red Blood Cell Health, Biological Aging and Healthy Aging, sponsored by ReCellience15, Inc. Not yet recruiting at 1 site in Canada. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by ReCellience15, Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study summary

This Phase II randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effects of pentadecanoic acid (C15:0) supplementation on red blood cell (RBC) health and predicted biological age in healthy adults aged 55 years and older. A total of 93 participants will be randomized to receive 200 mg of C15:0, 300 mg of C15:0, or placebo daily for approximately 12 weeks. The primary objective is to assess the effect of C15:0 on red blood cell distribution width (RDW-CV), a marker of RBC health, compared with placebo. Secondary outcomes include measures of inflammation, hematologic and iron metabolism markers, circulating C15:0 levels, biological age-related biomarkers, sleep quality, fatigue, energy, and health-related quality of life. Safety and tolerability will also be evaluated throughout the study.

Read the detailed description

This Phase II, randomized, double-blind, placebo-controlled, parallel-group study is designed to evaluate the effects of supplemental pentadecanoic acid (C15:0) on red blood cell (RBC) health and activity and predicted biological age in healthy older adults. The study will enroll 93 generally healthy men and women aged 55 years and older who have maintained stable dietary habits, medication and supplement use, and lifestyle practices prior to study entry.

Participants will be randomized in a 1:1:1 ratio to receive one of three interventions: C15:0 (200 mg/day), C15:0 (300 mg/day), or placebo. Study product will be administered orally as three capsules daily for a total supplementation period of approximately 84 days (12 weeks). Participants will attend a screening visit, a baseline/randomization visit, a Week 6 interim visit, and a Week 12 end-of-study visit.

The primary objective is to assess the effect of C15:0 supplementation on RBC health as measured by change from baseline in red blood cell distribution width coefficient of variation (RDW-CV) at Week 12 compared with placebo. Secondary objectives include evaluation of effects on RDW-CV at Week 6, systemic inflammation as measured by C-reactive protein (CRP), hemoglobin, hematocrit, RBC count, iron and RBC metabolism markers (reticulocytes, mean corpuscular hemoglobin concentration, serum iron, ferritin, and transferrin saturation), circulating C15:0 concentrations, and biomarkers associated with biological aging.

Biological aging outcomes include Phenotypic Age Acceleration (PhenoAgeAccel) score and the specific biological age-related biomarkers (glucose, mean corpuscular volume, white blood cell count and differential, creatinine, alkaline phosphatase, albumin, and lymphocyte percentage). Additional assessments will evaluate sleep quality, fatigue, energy, and health-related quality of life using the PROMIS Sleep Disturbance 8a, PROMIS Fatigue 8a, Energy Visual Analog Scale, and RAND-36 Health Survey, respectively.

Exploratory analyses will assess biomarkers of biological aging and oxidative stress, including interleukin-6 (IL-6) and malondialdehyde (MDA). Safety evaluations will include adverse events, vital signs, anthropometric measurements, and clinical laboratory assessments throughout the study.

The study aims to determine whether C15:0 supplementation can improve markers of RBC health and function while positively influencing biological aging-related pathways in healthy older adults.

02

Conditions studied

  • Red Blood Cell Health
  • Biological Aging
  • Healthy Aging

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Keywords

  • Pentadecanoic Acid (C15:0)
  • Red Blood Cell Health
  • Red Blood Cell Distribution Width (RDW)
  • Biological Aging
  • Healthy Aging
  • Healthy Older Adults
  • C-Reactive Protein (CRP)
  • Inflammation
03

In context

Inflammation

3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.

This study's planned enrollment of 93 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

This is the only study on the registry with ReCellience15, Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults who are 55 years or older at the time of signing the .
  • In otherwise good general health, as deemed by the investigator.
  • Are able to consume the study product capsules.
  • Stable medication regimen for ≥3 months
  • Have a between 18.5 to 34.9 kg/m2 (inclusive) at baseline.
  • Willing and able to fast overnight (approximately 10 hours)
  • Have maintained consistent dietary habits, including medication and supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study (unless required per the restrictions).
  • Agree to follow the restrictions on concomitant treatments.
  • Agree to follow the restrictions on lifestyle.
  • Agree to use acceptable methods.
  • Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

Exclusion criteria

Exclusion Criteria:

  • Individuals who are pregnant, intending to breastfeed, or intending to conceive at the time of consent and during the study, or demonstrate a positive pregnancy test
  • Have a known sensitivity, intolerability, or allergy to any of the study products or their .at baseline.
  • Have Type I diabetes or Type II diabetes, or uncontrolled thyroid disease ("uncontrolled" defined as being unmedicated, have an unstable use of medication within 3 months prior to screening, or have a stable use of medication for 3 months but still have uncontrolled conditions).
  • History of heart/cardiovascular disease (e.g. coronary artery disease, heart failure, stroke/, arrhythmia, uncontrolled hypertension). Participants receiving antihypertensive medications may be included, provided treatment has been stable for at least 8 weeks prior to screening, with no anticipated changes during the study.
  • Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
  • Have hematologic disorders affecting RBC production.
  • Have fat absorption issues.
  • Recent blood donation (\<8 weeks).
  • Have a history of renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or (i.e., /AIDS).
  • Have a history of cancer (except localized skin cancer without or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit.
  • Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
  • Major surgery in 3 months prior to screening or planned major surgery during the study.
  • Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) or use that in the opinion of the investigator may be of a concern for the study.
  • Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
  • Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
93 participants (estimated)

Study arms

  • Experimental
    Pentadecanoic Acid (200 mg/day)

    Participants receive 200 mg/day pentadecanoic acid (C15:0) administered as three capsules daily (2 active capsules and 1 placebo capsule) for approximately 12 weeks.

    Dietary Supplement: Pentadecanoic Acid

  • Experimental
    Pentadecanoic Acid (300 mg/day)

    Participants receive 300 mg/day pentadecanoic acid (C15:0) administered as three active capsules daily for approximately 12 weeks.

    Dietary Supplement: Pentadecanoic Acid

  • Placebo comparator
    Placebo

    Participants receive three placebo capsules daily for approximately 12 weeks. Placebo capsules are matched to the active study product in appearance and packaging.

    Other: Placebo

Interventions

  • Dietary supplementPentadecanoic Acid

    Pentadecanoic acid is administered orally as capsules once daily with the participant's first meal for approximately 12 weeks (84 ± 2 days). Participants receive one daily dose consisting of three capsules. The 200 mg/day group receives two active capsules and one placebo capsule, while the 300 mg/day group receives three active capsules. Participants take their first dose in-clinic on Day 1 and continue daily dosing at home from Day 2 through the day before the end-of-study visit.

    Also known as: C15:0

  • OtherPlacebo

    Placebo is administered orally as three matching placebo capsules once daily with the participant's first meal for approximately 12 weeks (84 ± 2 days). Placebo capsules are manufactured to match the active study product in physical appearance and packaging to maintain blinding.

06

What researchers measure

Primary outcomes

  1. To assess the effect of the test product (TP) at two dose levels on red blood cell (RBC) health, as measured by red blood cell distribution width (RDW), compared to placebo

    Change from baseline in RDW-CV (%) at Week 12, adjusted for baseline RDW, comparing each active dose (200 mg/day and 300 mg/day) to placebo

    Time frame: Change from baseline at Week 12

Secondary outcomes

  1. To evaluate early changes in RBC health at two dose levels, as measured by RDW, compared to placebo

    Change from baseline in RDW-CV (%) at Week 6, adjusted for baseline RDW, comparing each active dose to placebo

    Time frame: Change from baseline at Week 6

  2. To assess the effect of the TP at two dose levels on systemic inflammation, as measured by C-reactive protein (CRP), compared to placebo

    Change from baseline in CRP (mg/L) at Week 6 and Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 6 and Week 12

  3. To evaluate the effect of the TP at two dose levels on hemoglobin levels compared to placebo

    Change from baseline in hemoglobin (g/dL) at Week 6 and Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 6 and Week 12

  4. To evaluate the effect of the TP at two dose levels on hematocrit compared to placebo

    Change from baseline in hematocrit (%) at Week 6 and Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 6 and Week 12

  5. To evaluate the effect of the TP at two dose levels on RBC count compared to placebo

    Change from baseline in RBC count (10¹²/L) at Week 6 and Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 6 and Week 12

  6. To evaluate the effect of the TP at two dose levels on circulating C15:0 fatty acid concentrations compared to placebo

    Change from baseline in plasma C15:0 levels and erythrocyte membrane fatty acid composition at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  7. To evaluate the effect of the TP at two dose levels on RBC metabolism markers compared to placebo

    Change from baseline in reticulocytes at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  8. To evaluate the effect of the TP at two dose levels on RBC metabolism markers compared to placebo

    Change from baseline in mean corpuscular hemoglobin concentration (MCHC) at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  9. To evaluate the effect of the TP at two dose levels on markers of iron status compared to placebo

    Change from baseline in serum iron at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  10. To evaluate the effect of the TP at two dose levels on markers of iron status compared to placebo

    Change from baseline in ferritin at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  11. To evaluate the effect of the TP at two dose levels on markers of iron status compared to placebo

    Change from baseline in transferrin saturation at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  12. To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo

    Change from baseline in glucose at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  13. To evaluate the effect of the TP at two dose levels on biological aging

    Change from baseline in Phenotypic Age Acceleration (PhenoAgeAccel) at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  14. To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo

    Change from baseline in mean corpuscular volume (MCV) at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  15. To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo

    Change from baseline in white blood cell (WBC) count + differential at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  16. To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo

    Change from baseline in creatinine at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  17. To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo

    Change from baseline in alkaline phosphatase (ALP) at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  18. To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo

    Change from baseline in albumin at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  19. To evaluate the effect of the TP at two dose levels on biological age-related biomarkers compared to placebo

    Change from baseline in lymphocyte % at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  20. To evaluate the effect of the TP at two dose levels on sleep quality compared to placebo

    Change from baseline in PROMIS Sleep Disturbance 8a at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  21. To evaluate the effect of the TP at two dose levels on energy compared to placebo

    Change from baseline in PROMIS Fatigue 8a at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  22. To evaluate the effect of the TP at two dose levels on energy compared to placebo

    Change from baseline in Energy Visual Analog Scale at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

  23. To evaluate the effect of the TP at two dose levels on health-related quality of life compared to placebo

    Change from baseline in RAND-36 at Week 12 comparing each active dose to placebo

    Time frame: Change from baseline at Week 12

Other outcomes

  1. To assess heart rate for safety

    Heart rate (bpm) is assessed for safety of the TP

    Time frame: From baseline to Week 12

  2. To assess blood pressure for safety

    Blood pressure (mmHg) assessed for safety of the TP

    Time frame: From baseline to Week 12

  3. To assess weight for safety

    Weight (kg) is assessed for safety of the TP

    Time frame: From baseline to Week 12

  4. To assess body mass index for safety

    Body Mass Index (kg/m2) is assessed for safety of the TP

    Time frame: From baseline to Week 12

  5. To assess mean corpuscular volume in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of hematology parameter, mean corpuscular volume.

    Time frame: From baseline to Week 12

  6. To assess mean corpuscular hemoglobin in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of hematology parameter, mean corpuscular hemoglobin.

    Time frame: From baseline to Week 12

  7. To assess mean corpuscular hemoglobin concentration in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of hematology parameter, mean corpuscular hemoglobin concentration.

    Time frame: From baseline to Week 12

  8. To assess white blood cell count and differential in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of hematology parameter, white blood cell count and differential.

    Time frame: From baseline to Week 12

  9. To assess platelet count in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of hematology parameter, platelet count.

    Time frame: From baseline to Week 12

  10. To assess mean platelet volume in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of hematology parameter, mean platelet volume.

    Time frame: From baseline to Week 12

  11. To assess urea in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, urea.

    Time frame: From baseline to Week 12

  12. To assess creatinine in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, creatinine.

    Time frame: From baseline to Week 12

  13. To assess total bilirubin in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, total bilirubin.

    Time frame: From baseline to Week 12

  14. To assess alkaline phosphatase in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, alkaline phosphatase.

    Time frame: From baseline to Week 12

  15. To assess aspartate aminotransferase in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, aspartate aminotransferase.

    Time frame: From baseline to Week 12

  16. To assess alanine aminotransferase in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, alanine aminotransferase.

    Time frame: From baseline to Week 12

  17. To assess fasting serum glucose in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, fasting serum glucose.

    Time frame: From baseline to Week 12

  18. To assess albumin in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, albumin.

    Time frame: From baseline to Week 12

  19. To assess globulin in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, globulin.

    Time frame: From baseline to Week 12

  20. To assess total protein in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, total protein.

    Time frame: From baseline to Week 12

  21. To assess sodium in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, sodium.

    Time frame: From baseline to Week 12

  22. To assess potassium in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, potassium.

    Time frame: From baseline to Week 12

  23. To assess estimated glomerular filtration rate in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, estimated glomerular filtration rate.

    Time frame: From baseline to Week 12

  24. To assess chloride in blood samples for safety

    Fasting blood samples will be collected to assess the safety and tolerability of the investigational product through evaluation of clinical chemistry parameter, chloride.

    Time frame: From baseline to Week 12

  25. To assess reports of adverse events for safety

    Reports of adverse events will be evaluated to assess the safety of the TP

    Time frame: From baseline to Week 12

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jun 2027, 5 months later.

Of 36 industry-sponsored phase 2 interventional studies under Inflammation, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 5 months is below that.

Counting every sponsor, half of 149 studies reached it within 29 months; a quarter within 16 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2026
First posted
Sep 10, 2026
StartEst.
Jan 2027
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Secondary outcomes
1 edited, 24 added, 5 removed, 1 more
What changed in the outcomes
  • Editedother outcomeTo assess theweight for safety of the TPTime frame: From baseline to Week 12
  • Addedother outcomeTo assess heart rate for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess blood pressure for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess body mass index for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess mean corpuscular volume in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess mean corpuscular hemoglobin in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess mean corpuscular hemoglobin concentration in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess white blood cell count and differential in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess platelet count in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess mean platelet volume in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess urea in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess creatinine in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess total bilirubin in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess alkaline phosphatase in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess aspartate aminotransferase in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess alanine aminotransferase in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess fasting serum glucose in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess albumin in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess globulin in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess total protein in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess sodium in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess potassium in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess estimated glomerular filtration rate in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess chloride in blood samples for safetyTime frame: From baseline to Week 12
  • Addedother outcomeTo assess reports of adverse events for safetyTime frame: From baseline to Week 12
  • Removedother outcomeTo assess the safety of the TP (Vitals)Time frame: From baseline to Week 12
  • Removedother outcomeTo assess the safety of the TP (Vitals)Time frame: From baseline to Week 12
  • Removedother outcomeTo assess the safety of the TP (Anthropometrics)Time frame: From baseline to Week 12
  • Removedother outcomeTo assess the safety of the TP (Anthropometrics)Time frame: From baseline to Week 12
  • Removedother outcomeTo assess the safety of the TP (Hematology Parameters)Time frame: From baseline to Week 12
  • …and 1 more, on the record history on ClinicalTrials.gov ↗
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Secondary outcomes 1 edited, 24 added, 5 removed, 1 more
    What changed in the outcomes
    • Editedother outcomeTo assess theweight for safety of the TPTime frame: From baseline to Week 12
    • Addedother outcomeTo assess heart rate for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess blood pressure for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess body mass index for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess mean corpuscular volume in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess mean corpuscular hemoglobin in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess mean corpuscular hemoglobin concentration in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess white blood cell count and differential in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess platelet count in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess mean platelet volume in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess urea in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess creatinine in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess total bilirubin in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess alkaline phosphatase in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess aspartate aminotransferase in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess alanine aminotransferase in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess fasting serum glucose in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess albumin in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess globulin in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess total protein in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess sodium in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess potassium in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess estimated glomerular filtration rate in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess chloride in blood samples for safetyTime frame: From baseline to Week 12
    • Addedother outcomeTo assess reports of adverse events for safetyTime frame: From baseline to Week 12
    • Removedother outcomeTo assess the safety of the TP (Vitals)Time frame: From baseline to Week 12
    • Removedother outcomeTo assess the safety of the TP (Vitals)Time frame: From baseline to Week 12
    • Removedother outcomeTo assess the safety of the TP (Anthropometrics)Time frame: From baseline to Week 12
    • Removedother outcomeTo assess the safety of the TP (Anthropometrics)Time frame: From baseline to Week 12
    • Removedother outcomeTo assess the safety of the TP (Hematology Parameters)Time frame: From baseline to Week 12
    • …and 1 more, on the record history on ClinicalTrials.gov ↗

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07812792
Lead sponsor
ReCellience15, Inc
Collaborators
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 5, 2026

Study contacts

Jevaneeh Rubio
Contact
jrubio@nutrasource.ca
519-341-3367
Stephanie Recker
Contact
srecker@nutrasource.ca
519-341-3367 ext. 109
Bruce Brown
study director · ReCellience15, Inc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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