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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05740670
• Other study ID #: 22VVCFB01
• Status: Completed
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: October 10, 2023

Study information

• Verified date: January 2024
• Source: Veyl Ventures LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Other:
• Dr. 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.

Locations

Country	Name	City	State
Canada	KGK Science Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Veyl Ventures LLC	KGK Science Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of pre-emergent and post-emergent adverse events (AE).		baseline to day 50
Other	Blood pressure (BP) at screening, baseline, day 22, day 28, and day 50 following the bone broth diet.		screening, baseline, day 22, day 28, day 50
Other	Heart rate (HR) at screening, baseline, day 22, day 28, and day 50 following the bone broth diet.		screening, baseline, day 22, day 28, day 50
Other	Serum aspartate aminotransferase (AST) measurement at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Serum alanine aminotransferase (ALT) measurement at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Serum alkaline phosphatase (ALP) measurement at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Serum total bilirubin measurement at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Creatinine measurement at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Measurement of electrolytes (sodium, potassium, chloride) at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Measurement of uric acid at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Estimated glomerular filtration rate (eGFR) at screening day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	White blood cell count (WBC) at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	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.	screening, day 22, day 50
Other	Red blood cell count (RBC) at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Hemoglobin at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Hematocrit at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Platelet count at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Immature granulocytes at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Nucleated red blood cells (RBC) at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	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).	screening, day 22, day 50
Other	Urine color and appearance at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Urinalysis-chemistry for urinary glucose at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Urinalysis-chemistry for urinary ketones at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Urinalysis-chemistry for urinary specific gravity at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Urinalysis-chemistry for blood at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Urinalysis-chemistry for urinary pH at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Urinalysis-chemistry for urinary proteins at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Urinalysis-chemistry for urinary nitrite at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Other	Urinalysis-chemistry for urinary leukocytes at screening, day 22, and day 50 following the bone broth diet.		screening, day 22, day 50
Primary	The change in weight from baseline at Days 22 and 50 following the bone broth diet.		baseline, day 22, day 50
Primary	The change in body mass index (BMI) from baseline at Days 22 and 50 following the bone broth diet.		baseline, day 22, day 50
Secondary	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.		baseline, day 22, day 28, day 50, day 56
Secondary	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.		baseline, day 22, day 28, day 50, day 56
Secondary	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.	baseline, day 22, day 28, day 50
Secondary	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.	baseline, day 22, day 28, day 50
Secondary	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.	baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.		baseline, day 22, day 28, day 50
Secondary	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.	baseline, day 22, day 28, day 50