Clinical trial NCT05740670: The Safety and Efficacy of a Bone Broth Diet on Weight Loss in Obese Adults
Official title: An Open-label Clinical Trial to Investigate the Safety and Efficacy of a Bone Broth Diet on Weight Loss in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Safety and efficacy
Weight loss
Obesity
Bone broth
Lead sponsor: Veyl Ventures LLC
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2023-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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:

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

Primary outcomes:
measure: The change in weight from baseline at Days 22 and 50 following the bone broth diet.
timeFrame: baseline, day 22, day 50
measure: The change in body mass index (BMI) from baseline at Days 22 and 50 following the bone broth diet.
timeFrame: baseline, day 22, day 50
Secondary outcomes:
measure: 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.
timeFrame: baseline, day 22, day 28, day 50, day 56
measure: 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.
timeFrame: baseline, day 22, day 28, day 50, day 56
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
measure: 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.
timeFrame: baseline, day 22, day 28, day 50
Other outcomes:
measure: The incidence of pre-emergent and post-emergent adverse events (AE).
timeFrame: baseline to day 50
measure: Blood pressure (BP) at screening, baseline, day 22, day 28, and day 50 following the bone broth diet.
timeFrame: screening, baseline, day 22, day 28, day 50
measure: Heart rate (HR) at screening, baseline, day 22, day 28, and day 50 following the bone broth diet.
timeFrame: screening, baseline, day 22, day 28, day 50
measure: Serum aspartate aminotransferase (AST) measurement at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Serum alanine aminotransferase (ALT) measurement at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Serum alkaline phosphatase (ALP) measurement at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Serum total bilirubin measurement at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Creatinine measurement at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Measurement of electrolytes (sodium, potassium, chloride) at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Measurement of uric acid at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Estimated glomerular filtration rate (eGFR) at screening day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: White blood cell count (WBC) at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: White blood cell count (WBC) with differentials at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Red blood cell count (RBC) at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Hemoglobin at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Hematocrit at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Platelet count at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Immature granulocytes at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Nucleated red blood cells (RBC) at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Red blood cell (RBC) indices at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Urine color and appearance at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Urinalysis-chemistry for urinary glucose at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Urinalysis-chemistry for urinary ketones at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Urinalysis-chemistry for urinary specific gravity at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Urinalysis-chemistry for blood at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Urinalysis-chemistry for urinary pH at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Urinalysis-chemistry for urinary proteins at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Urinalysis-chemistry for urinary nitrite at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
measure: Urinalysis-chemistry for urinary leukocytes at screening, day 22, and day 50 following the bone broth diet.
timeFrame: screening, day 22, day 50
Locations:
city: London
country: Canada
facility: KGK Science Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References: