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

NCT05740670 | Completed

• 1 other identifier: 22VVCFB01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Weight Loss

Keywords

Safety and efficacy; Weight loss; Obesity; Bone broth

Outcome Measures

Primary Outcomes (2)

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

  baseline, day 22, day 50

• 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 Outcomes (20)

• 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

• 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

• 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.

  baseline, day 22, day 28, day 50

• 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.

  baseline, day 22, day 28, day 50

• 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.

  baseline, day 22, day 28, day 50

Other Outcomes (29)

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

  baseline to day 50

• 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

• 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

Study Arms (1)

Dr. Kellyann's Bone Broth

EXPERIMENTAL

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

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.

Dr. Kellyann's Bone Broth

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Veyl Ventures LLC: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B 3L1, Canada

Location

MeSH Terms

Conditions

Weight Loss; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 23, 2023
• Study Start: January 25, 2023
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CA (1)