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

100 Participants Needed

Trial Summary

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 the Bone Broth Diet safe for weight loss in obesity?

The research on very low calorie diets, which are somewhat similar to the Bone Broth Diet, shows they can be safe for weight loss in obese patients, with no major side effects reported. Routine health checks showed no significant changes in important health markers like blood proteins and cholesterol. ^{1 2 3 4 5}

How does Dr. Kellyann's Bone Broth treatment for obesity differ from other treatments?

Dr. Kellyann's Bone Broth treatment is unique because it focuses on using bone broth as a dietary component, which may offer benefits like improved gut health and nutrient intake, unlike traditional low-calorie or ketogenic diets that primarily focus on macronutrient composition. This approach may also help mitigate bone loss often associated with weight loss, as bone broth is rich in minerals that support bone health. ^{6 7 8 9 10}

What is the purpose of this trial?

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. The diet works by providing a low-calorie, filling food option that might help people eat less and lose weight.

Research Team

David Crowley, MD

Principal Investigator

KGK Science Inc.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A long-term evaluation of very low calorie semi-synthetic diets: an inpatient/outpatient study with egg albumin as the protein source. [2014]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Diet Quality and Micronutrient Intake among Long-Term Weight Loss Maintainers. [2020]

3. England pubmed.ncbi.nlm.nih.gov

MANAGEMENT OF ENDOCRINE DISEASE: Bone complications of bariatric surgery: updates on sleeve gastrectomy, fractures, and interventions. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Micronutrient Gaps in Three Commercial Weight-Loss Diet Plans. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Nutrient intake and obesity in a multidisciplinary assessment of osteoarthritis. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of a Very Low-Calorie Ketogenic Diet on Weight Regain Following Bariatric Surgery. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Bone consequences of intentional weight loss in overweight or obese patients]. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Bone loss accompanying voluntary weight loss in obese humans. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

The diet prescription for obesity. What works? [2005]

10. United States pubmed.ncbi.nlm.nih.gov

Changes in Bone Mineral Density After Weight Loss Due to Metabolic Surgery or Lifestyle Intervention in Obese Patients. [2021]