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Completed

NCT Number: NCT05740670

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

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).

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KGK Science Inc.

London, Ontario, N6B 3L1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females between the age of 35-65 years, inclusive, at screening
  • BMI between 30.0 and 39.9 kg/m2
  • 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
  • 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
  • Motivated to comply with dietary and fasting guidelines as assessed by the Motivation Questionnaire at screening (see Appendix 16.2)
  • 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
  • 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
  • Provided voluntary, written, informed consent to participate in the study

Exclusion criteria

  • Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
  • Allergy, sensitivity, or intolerance to the investigational product's ingredients
  • Metal implants or other physical characteristics/limitations that may affect DEXA scan results, as assessed by the QI
  • Participation within the last three months in any weight loss or diet programs from baseline
  • Current or history of eating disorders, as assessed by the QI
  • Obesity-induced by metabolic or endocrinologic disorders (ex. acromegaly, hypothalamic obesity), as assessed by the QI
  • Current or history of significant diseases of the gastrointestinal tract, as assessed by the QI
  • Gastric bypass surgery or other surgeries to induce weight loss
  • History of gout and have had a flare up within past 12 months
  • Chronic inflammatory diseases, as assessed by the QI
  • Type I or Type II diabetes (HbA1c ≥6.5%)
  • 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
  • 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
  • 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
  • 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
  • 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)
  • Regular use of tobacco products within 6 months of baseline and during the study period, as assessed by the QI
  • 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
  • Alcohol or drug abuse within the last 12 months
  • Use of medical cannabinoid products
  • Chronic use of cannabinoid products (>2 times/week). Occasional users must agree to wash out and abstain during the study period
  • Clinically significant abnormal laboratory results at screening, as assessed by the QI
  • Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the end of study
  • Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
  • Individuals who are unable to give informed consent
  • 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

Treatment and study plan

Dr. Kellyann's Bone Broth

Other

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.

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.

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

    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.

  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.

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

    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.

  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.

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

    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.

  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.

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

    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.

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.

    Time frame: screening, day 22, day 50

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

    Time frame: screening, day 22, day 50

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

  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

Sponsors and collaborators

Lead sponsor

Veyl Ventures LLC

Industry

Collaborators

  • KGK Science Inc.

Registry information

Official study title

An Open-label Clinical Trial to Investigate the Safety and Efficacy of a Bone Broth Diet on Weight Loss in Obese Adults

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2023
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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