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CompletedNCT05740670Updated Jan 30, 2024

The Safety and Efficacy of a Bone Broth Diet on Weight Loss in Obese Adults

An interventional study of Dr. Kellyann's Bone Broth in Weight Loss, sponsored by Veyl Ventures LLC. Completed at 1 site in Canada. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by Veyl Ventures LLC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
35 Years to 65 Years
Sex
All
01

Study summary

The primary objective of this study is to investigate the safety and efficacy of a bone broth diet on weight loss in obese adults. The change in weight and body mass index (BMI) following the bone broth diet will be measured from baseline at Days 22 and 50. Additionally, the safety and tolerability of the bone broth diet will be measured by the occurrence of post-emergent adverse events (AEs).

02

Conditions studied

  • Weight Loss

Keywords

  • Safety and efficacy
  • Weight loss
  • Obesity
  • Bone broth
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 100 is above the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

This is the only study on the registry with Veyl Ventures LLC as lead sponsor.

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

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Males and females between the age of 35-65 years, inclusive, at screening
  2. BMI between 30.0 and 39.9 kg/m2

  3. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening

    Or,

    Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

    • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
    • Double-barrier method
    • Intrauterine devices
    • Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
    • Vasectomy of partner at least 6 months prior to screening
    • Abstinence and agrees to use contraception if planning on becoming sexually active
  4. Agrees to maintain current lifestyle habits as much as possible throughout the study depending on your ability to maintain the following: medications, supplements, and sleep
  5. Motivated to comply with dietary and fasting guidelines as assessed by the Motivation Questionnaire at screening (see Appendix 16.2)
  6. Self-reported stable body weight for the past three months defined as not having gained or lost more than 5 kg of body weight throughout the three months prior to screening
  7. Willingness and ability to complete questionnaires, records, and diaries associated with the study, adhere to dietary/fasting guidelines, read the Revised Bone Broth Diet book (chapters 1-5), and to complete all clinic visits
  8. Provided voluntary, written, informed consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
  2. Allergy, sensitivity, or intolerance to the investigational product's ingredients
  3. Metal implants or other physical characteristics/limitations that may affect DEXA scan results, as assessed by the QI
  4. Participation within the last three months in any weight loss or diet programs from baseline
  5. Current or history of eating disorders, as assessed by the QI
  6. Obesity-induced by metabolic or endocrinologic disorders (ex. acromegaly, hypothalamic obesity), as assessed by the QI
  7. Current or history of significant diseases of the gastrointestinal tract, as assessed by the QI
  8. Gastric bypass surgery or other surgeries to induce weight loss
  9. History of gout and have had a flare up within past 12 months
  10. Chronic inflammatory diseases, as assessed by the QI
  11. Type I or Type II diabetes (HbA1c ≥6.5%)
  12. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
  13. Current unstable diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
  14. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
  15. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
  16. Current use of any prescribed or over-the counter medications and/or supplements that may affect body weight or metabolism, as assessed by the QI (See Sections 7.3.1and 7.3.2)
  17. Regular use of tobacco products within 6 months of baseline and during the study period, as assessed by the QI
  18. Alcohol intake average of >2 standard drinks per day. Occasional users must agree to wash out and abstain during the study period, as assessed by the QI
  19. Alcohol or drug abuse within the last 12 months
  20. Use of medical cannabinoid products
  21. Chronic use of cannabinoid products (>2 times/week). Occasional users must agree to wash out and abstain during the study period
  22. Clinically significant abnormal laboratory results at screening, as assessed by the QI
  23. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the end of study
  24. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
  25. Individuals who are unable to give informed consent
  26. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Dr. Kellyann's Bone Broth

    During the bone broth phases, each week will be separated into 'fasting days' and 'feeding days'. There will be 2 non-consecutive fasting days and 5 feeding days per week. On fasting days, participants will be instructed to consume 1 packet of bone broth every 2 hours, for a total of 7 packets/day. On feeding days, participants will consume 3 meals/day, made up of 'Yes' foods portioned according to instructions provided in the Bone Broth Diet Quick Reference Guide and 1 packet of bone broth, twice a day, as snacks between meals. If a bone broth serving is missed participants are instructed to consume the serving as soon as they remember. Participants will be advised not to exceed 7servings of bone broth on fasting days and 2 servings on feeding days. During the maintenance phase, participants will not consume any bone broth.

    Other: Dr. Kellyann's Bone Broth

Interventions

  • OtherDr. Kellyann's Bone Broth

    Participants will have two bone broth phases, each three weeks in length. Bone broth phases will be separated by a one-week maintenance phase. A one-week maintenance phase will also occur after the second bone broth phase. Each week of a broth phase will consist of five feeding days and five fasting days. On feeding days, participants will consume one packet of bone broth, twice each day, as snacks between meals. On fasting days, participants will consume one packet of bone broth every two hours for a total of seven packets each day.

06

What researchers measure

Primary outcomes

  1. The change in weight from baseline at Days 22 and 50 following the bone broth diet.

    Time frame: baseline, day 22, day 50

  2. The change in body mass index (BMI) from baseline at Days 22 and 50 following the bone broth diet.

    Time frame: baseline, day 22, day 50

Secondary outcomes

  1. The change in weight from baseline at Day 28, from Day 22 at Day 28, from Day 28 at Day 50, and from Day 50 at Day 56 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50, day 56

  2. The change in body mass index (BMI) from baseline at Day 28, from Day 22 at Day 28, from Day 28 at Day 50, and from Day 50 at Day 56 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50, day 56

  3. The change in android/gynoid fat ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    The change in android/gynoid fat ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet as assessed by DEXA measurements.

    Time frame: baseline, day 22, day 28, day 50

  4. The change in fat mass (percent or grams) from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    The change in fat mass from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet as assessed by DEXA measurements.

    Time frame: baseline, day 22, day 28, day 50

  5. The change in muscle mass (percent or grams) from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    The change in muscle mass from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet as assessed by DEXA measurements.

    Time frame: baseline, day 22, day 28, day 50

  6. The change in waist circumference from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  7. The change in sagittal abdominal diameter (SAD) from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  8. The change in hip circumference from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  9. The change in arm circumference from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  10. The change in thigh circumference from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  11. The change in waist-to-hip ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  12. The change in blood glucose levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  13. The change in triglyceride levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  14. The change in total cholesterol levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  15. The change in high-density lipoprotein cholesterol (HDL-C) levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  16. The change in non-high-density lipoprotein cholesterol (non-HDL-C) levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  17. The change in low-density lipoprotein cholesterol (LDL-C) levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  18. The change in triglyceride to high-density cholesterol ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  19. The change in low-density cholesterol to high-density cholesterol ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    Time frame: baseline, day 22, day 28, day 50

  20. The change in quality of life from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.

    The change in quality of life is assessed by the Modified Short Form (SF)-36 Quality of Life Questionnaire from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. The SF-36 measures nine scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and reported health transition. The scores range from 0 to 100 where higher scores indicate a better state of health.

    Time frame: baseline, day 22, day 28, day 50

Other outcomes

  1. The incidence of pre-emergent and post-emergent adverse events (AE).

    Time frame: baseline to day 50

  2. Blood pressure (BP) at screening, baseline, day 22, day 28, and day 50 following the bone broth diet.

    Time frame: screening, baseline, day 22, day 28, day 50

  3. Heart rate (HR) at screening, baseline, day 22, day 28, and day 50 following the bone broth diet.

    Time frame: screening, baseline, day 22, day 28, day 50

  4. Serum aspartate aminotransferase (AST) measurement at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  5. Serum alanine aminotransferase (ALT) measurement at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  6. Serum alkaline phosphatase (ALP) measurement at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  7. Serum total bilirubin measurement at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  8. Creatinine measurement at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  9. Measurement of electrolytes (sodium, potassium, chloride) at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  10. Measurement of uric acid at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  11. Estimated glomerular filtration rate (eGFR) at screening day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  12. White blood cell count (WBC) at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  13. White blood cell count (WBC) with differentials at screening, day 22, and day 50 following the bone broth diet.

    WBC with differentials (neutrophils, lymphocytes, monocytes, eosinophils, basophils) will be measured in the serum at screening, day 22, and day 50.

    Time frame: screening, day 22, day 50

  14. Red blood cell count (RBC) at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  15. Hemoglobin at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  16. Hematocrit at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  17. Platelet count at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  18. Immature granulocytes at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  19. Nucleated red blood cells (RBC) at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  20. Red blood cell (RBC) indices at screening, day 22, and day 50 following the bone broth diet.

    RBC indices include mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and red blood cell distribution width (RDW).

    Time frame: screening, day 22, day 50

  21. Urine color and appearance at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  22. Urinalysis-chemistry for urinary glucose at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  23. Urinalysis-chemistry for urinary ketones at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  24. Urinalysis-chemistry for urinary specific gravity at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  25. Urinalysis-chemistry for blood at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  26. Urinalysis-chemistry for urinary pH at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  27. Urinalysis-chemistry for urinary proteins at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  28. Urinalysis-chemistry for urinary nitrite at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

  29. Urinalysis-chemistry for urinary leukocytes at screening, day 22, and day 50 following the bone broth diet.

    Time frame: screening, day 22, day 50

07

Study locations

1 site
  • KGK Science Inc.
    London, Ontario N6B 3L1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05740670
Lead sponsor
Veyl Ventures LLC
Collaborators
KGK Science Inc.
Responsible party
Sponsor
First posted
Feb 23, 2023
Start date
Jan 25, 2023
Primary completion
Oct 10, 2023
Completion
Oct 10, 2023
Last update
Jan 30, 2024

Study contacts

David Crowley, MD
principal investigator · KGK Science Inc.

Oversight

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

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