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CompletedNCT05199012Updated Sep 13, 2023

Oral Supplementation With a Black Pepper Extract

An interventional study of Black pepper extract in Waist Circumference, Triglycerides and Appetite, sponsored by The Center for Applied Health Sciences, LLC. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by The Center for Applied Health Sciences, LLC · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study summary

This study is a randomized, placebo-controlled, double-blind, two-arm trial of N=94 apparently healthy men and women to be recruited at a single investigational center in Northeast Ohio. Subjects will attend three study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, physical exam, routine blood work, background baseline diet). Over the next 12 weeks, subjects will attend Visits 2 (baseline) and 3 (week 12), wherein assessments of body weight, waist circumference, urinary ketones, serum glucose, insulin, liver enzymes as well as other biomarkers of metabolic health, quality of life (SF-36 questionnaire), and various visual analog scales (VAS) for appetite, satiety, and cravings will be made.

02

Conditions studied

  • Waist Circumference
  • Triglycerides
  • Appetite
  • Inflammation
  • Lipids

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03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 86 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

The Center for Applied Health Sciences, LLC is the lead sponsor of 13 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Provide voluntary signed and dated informed consent.
  • Be in good health as determined by medical history and routine blood chemistries.
  • Age between the ages of 21 and 65 (inclusive).
  • Body Mass Index of 25-34.99 (inclusive).
  • Body weight of at least 120 pounds.
  • Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic blood pressure \< 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
  • Normal seated, resting heart rate (\<90 per minute).
  • Willing to duplicate their previous 24-hour diet, refrain from caffeine for 12 hr, abstain from exercise for 24 hr, and fast for 10 hours prior to each laboratory visit.

Exclusion criteria

Exclusion Criteria:

  • History of unstable or new-onset cardiovascular or cardiorespiratory disease.
  • Individuals diagnosed with diabetes or other endocrine disorder.
  • Fasting blood sugar of > 126 mg/dL OR HgA1c of > 6.5%.
  • History of use of medications or dietary supplements known to affect glycemia or insulinemia.
  • Current use of amiodarone, anti-retroviral agents, corticosteroids, methotrexate, tamoxifen, valproate, amitriptyline (Elavil), codeine, desipramine (Norpramin), flecainide (Tambocor), haloperidol (Haldol), imipramine (Tofranil), metoprolol (Lopressor, Toprol XL), ondansetron (Zofran), paroxetine (Paxil), risperidone (Risperdal), tramadol (Ultram), venlafaxine (Effexor), cyclosporine, lithium, chlorzoxazone, theophylline, and bufuralol, cyclophosphamide, ifosfamide, barbiturates, bromobenzene, lovastatin (Mevacor), ketoconazole (Nizoral), itraconazole (Sporanox), fexofenadine (Allegra), triazolam (Halcion), glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, pioglitazone (Actos), rosiglitazone (Avandia), etoposide, paclitaxel, vinblastine, vincristine, vindesine, amprenavir, indinavir, nelfinavir, saquinavir, cimetidine, ranitidine, diltiazem, verapamil, digoxin, erythromycin, cisapride (Propulsid),, loperamide (Imodium), quinidine, aspirin, clopidogrel (Plavix), dalteparin (Fragmin), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin), nevirapine, Pentobarbital (Nembutal), Phenytoin (Dilantin), Propranolol (Inderal), Rifampin, Amoxicillin (Amoxil, Trimox), Carbamazepine (Tegretol), Cefotaxime (Claforan), midazolam, diclofenac.
  • History of hyperparathyroidism or an untreated thyroid disease.
  • History of nephrotic syndrome or renal disease.
  • History of alcohol abuse within the past year.
  • History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
  • Prior gastrointestinal bypass surgery (Lapband), etc.
  • Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
  • Chronic inflammatory condition or autoimmune disease (e.g., rheumatoid arthritis, hepatitis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
  • Female subjects who are pregnant, trying to become pregnant, or lactating. Women who participate in this study must agree to the use of contraception for the duration of the study and any woman that is sexually active will have to have a negative pregnancy test prior to enrolling. Women of childbearing age (any woman prior to menopause or surgically sterilized) regardless of their use of contraception will be provided a urine pregnancy test kit at their screening visit and take the test in private using the female lavatory after signing an informed consent.
  • Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of- Analysis.
  • Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
  • Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
86 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo is maltodextrin, delivered as 2 capsules.

    Dietary Supplement: Black pepper extract

  • Active comparator
    Active

    The active comparator is black pepper extract, delivered as 2 capsules.

    Dietary Supplement: Black pepper extract

Interventions

  • Dietary supplementBlack pepper extract

    Subjects will be randomized to receive either the placebo or active (black pepper extract) in a 1:1

06

What researchers measure

Primary outcomes

  1. waist circumference

    measurement of waist circumference in centimeters

    Time frame: Change from baseline to week 12

  2. triglycerides

    measurement of triglycerides in blood

    Time frame: Change from baseline to week 12

Secondary outcomes

  1. urinary ketones

    ketone concentration in urine

    Time frame: Change from baseline to week 12

  2. plasma free fatty acids

    concentration of free fatty acids in plasma

    Time frame: Change from baseline to week 12

  3. body weight

    body weight measurement in kg

    Time frame: Change from baseline to week 12

  4. Body mass index

    body mass index (body weight relative to height)

    Time frame: Change from baseline to week 12

  5. liver enzymes

    fasting levels of ALT and AST measured in international units per liter (IU/L)

    Time frame: Change from baseline to week 12

Other outcomes

  1. Appetite

    appetite as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings.

    Time frame: Change from baseline to week 12

  2. Satiety

    satiety as measured with a 10 cm anchored visual analogue scale, where higher values represent greater satiety.

    Time frame: Change from baseline to week 12

  3. Cravings

    cravings as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings.

    Time frame: Change from baseline to week 12

  4. Short Form Health Survey (SF-36)

    health status as measured with the SF-36 questionnaire, where scores range from 0 to 100, and higher values represent better health status.

    Time frame: Chnage from baseline to week 12

07

Study locations

1 site
  • The Center for Applied Health Sciences
    Canfield, Ohio 44406, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05199012
Lead sponsor
The Center for Applied Health Sciences, LLC
Collaborators
Brightseed, Inc
Responsible party
Sponsor
First posted
Jan 20, 2022
Start date
Dec 15, 2021
Primary completion
Dec 15, 2022
Completion
Dec 15, 2022
Last update
Sep 13, 2023

Oversight

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

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