Bone Broth Diet for Weight Loss in Obesity

Overseen By Erin Lewis, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Veyl Ventures LLC

Must not be taking: Weight loss drugs

Disqualifiers: Pregnancy, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a bone broth diet can aid weight loss in adults with obesity. Participants will follow a specific eating plan that includes fasting and regular meals with Dr. Kellyann's Bone Broth to determine its effects on weight loss and body mass index (BMI). The study will monitor safety by checking for any side effects. Individuals with a stable body weight for the past three months and a BMI between 30.0 and 39.9 may qualify. As an unphased trial, this study offers a unique opportunity to contribute to innovative research on diet and weight management.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that current use of medications affecting body weight or metabolism may be assessed by the investigator. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that Dr. Kellyann's Bone Broth is safe for weight loss in obese adults?

Research has shown that Dr. Kellyann's Bone Broth diet appears safe for people with obesity. In past studies, participants generally found the diet easy to follow. Most side effects, if any, were mild and manageable, such as minor digestive issues or changes in appetite. Importantly, these studies reported no serious health problems.

This suggests that the bone broth diet is safe for weight loss. However, always consult a healthcare provider before starting any new diet or treatment, especially if existing health conditions are present. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard weight loss treatments, which often involve medications or surgical interventions, Dr. Kellyann's Bone Broth offers a natural and dietary approach through its unique structure of alternating fasting and feeding days. This method incorporates bone broth as both a meal replacement and a snack, which may help control hunger while providing nutrients. Researchers are excited about this treatment because it could offer a more accessible and less invasive option for individuals struggling with obesity, potentially leading to weight loss without the side effects associated with more aggressive treatments.

What evidence suggests that Dr. Kellyann's Bone Broth might be an effective treatment for obesity?

Studies have shown that collagen, a key component of bone broth, can help reduce body fat. Some individuals on a bone broth diet have gained muscle while losing weight. However, direct scientific proof that Dr. Kellyann's Bone Broth Diet alone causes weight loss is lacking. This trial will investigate how this specific diet might aid weight loss in overweight adults. ^{1 2 3 4 6}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

Adults aged 35-65 with obesity (BMI between 30.0 and 39.9) who haven't had major surgery recently or plan to during the study, don't smoke, aren't drug/alcohol abusers, have stable weight for the past three months, and are not on medications affecting weight. Women must be non-childbearing or use birth control; men with vasectomy qualify.

Inclusion Criteria

Your body mass index (BMI) is between 30 and 39.9, which means you may be overweight or have obesity.

Males and females between the age of 35-65 years, inclusive, at screening

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

Exclusion Criteria

Type I or Type II diabetes (HbA1c ≥6.5%)

You have been using tobacco products regularly within the past 6 months and plan to continue using them during the study.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants follow a bone broth diet with fasting and feeding days, with measurements taken at Days 22, 28, and 50

7 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dr. Kellyann's Bone Broth

Trial Overview The trial is testing Dr. Kellyann's Bone Broth Diet to see if it helps obese adults lose weight safely. Participants will follow the diet and their weight loss and BMI changes will be tracked at specific intervals while monitoring for any adverse events.

How Is the Trial Designed?

Group I: Dr. Kellyann's Bone Broth Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Veyl Ventures LLC

Lead Sponsor

Trials

1

Recruited

100+

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Published Research Related to This Trial

Weight reduction is crucial for managing obesity and its related conditions like diabetes and hypertension, and both high-carbohydrate/low-fat and higher-protein/low-carbohydrate diets can lead to fat loss if calorie intake is sufficiently low.

For bariatric patients, low-calorie diets, protein-sparing modified fasts, and modified-carbohydrate diets are the most effective for compliance and long-term weight maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The diet prescription for obesity. What works? Holtmeier, KB., Seim, HC.[2005]

Bariatric surgery, particularly sleeve gastrectomy, is associated with significant bone loss, raising concerns about skeletal health in patients undergoing this procedure.

There is emerging evidence linking bariatric surgery to an increased risk of fractures, highlighting the need for intervention strategies to prevent bone loss in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MANAGEMENT OF ENDOCRINE DISEASE: Bone complications of bariatric surgery: updates on sleeve gastrectomy, fractures, and interventions. Beavers, KM., Greene, KA., Yu, EW.[2023]

In a study of 77 osteoarthritis patients over 12 weeks, 79% were found to be obese, which was linked to increased pain from osteoarthritis, indicating that weight management could be crucial for pain relief.

The patients had dietary deficiencies in key nutrients like vitamin D and zinc, suggesting that improving nutrition alongside weight loss could enhance their overall management of osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrient intake and obesity in a multidisciplinary assessment of osteoarthritis. White-O'Connor, B., Sobal, J.[2013]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2667268525000488

An open-label clinical trial to investigate the safety and ... Supplementation with collagen, the key ingredient in bone broth, has been shown to significantly reduce the percentage and total amount of body fat in a ...

2. withpower.com withpower.com/trial/phase-body-weight-2023-a463f

Bone Broth Diet for Weight Loss in Obesity This trial is testing a bone broth diet to see if it helps obese adults lose weight. The study will measure changes in weight and BMI.

3. ctv.veeva.com ctv.veeva.com/study/the-safety-and-efficacy-of-a-bone-broth-diet-on-weight-loss-in-obese-adults

The Safety and Efficacy of a Bone Broth Diet on Weight Loss ... The primary objective of this study is to investigate the safety and efficacy of a bone broth diet on weight loss in obese adults.

4. clinicalnutritionopenscience.com clinicalnutritionopenscience.com/article/S2667-2685(25)00048-8/pdf

Clinical Nutrition Open Science While muscle mass loss during weight loss is commonly reported [34], participants following the BBD had a significant increase in muscle mass ...

5. legionathletics.com legionathletics.com/bone-broth-diet/?srsltid=AfmBOoqtsLcuM7kFs9iGtZ2wTXCkivocgsj5Z5F0CJXrIvIX-7Lm2zbw

A Review on the Impacts of the Bone Broth Diet The Bone Broth Diet and Weight Loss ... No scientific studies have looked at how effective the Bone Broth Diet is at helping you lose weight.

6. amazon.com amazon.com/Kellyanns-Bone-Broth-Diet-Inches/dp/1623366704

Dr. Kellyann's Bone Broth Diet: Lose Up to 15 Pounds, 4 ... A 21-day weight loss and anti-aging program centered on bone broth consumption, mini-fasting, and fitness routines. Includes recipes and promises fat burning, ...