What side effects are associated with this type of intervention?

Common side effects of nutritional interventions aimed at reducing caloric intake, such as the Bone Broth Diet, include gastrointestinal issues like constipation, diarrhea, and bloating. Other potential side effects are nutrient deficiencies, fatigue, dizziness, and headaches due to reduced caloric and nutrient intake. It's important to monitor these symptoms and consult with a healthcare provider to ensure the diet is balanced and safe.

What prior FDA approvals exist?

The FDA has approved several drugs for weight loss that align with nutritional interventions aimed at reducing caloric intake. These include orlistat, which reduces fat absorption, and appetite suppressants like phentermine-topiramate and liraglutide. These medications work by either decreasing appetite or altering the body's metabolism to promote weight loss. While the Bone Broth Diet focuses on a nutritional approach, these pharmacological treatments offer complementary strategies for managing obesity.

What other types of research exist?

Promising, novel alternatives to the Bone Broth Diet for weight loss include: 1) The Mediterranean Diet, which has been shown to reduce the incidence of type 2 diabetes and improve cardiovascular health. 2) The DASH Diet (Dietary Approaches to Stop Hypertension), which is effective in reducing blood pressure and promoting overall health. 3) Intermittent Fasting, which has gained popularity for its potential benefits in weight loss and metabolic health. 4) Low-Carb and Ketogenic Diets, which have been effective in promoting weight loss and improving metabolic parameters. These alternatives are supported by clinical evidence and offer varied approaches to caloric reduction and nutritional balance.

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Bone Broth Diet for Weight Loss in Obesity

N/A

Waitlist Available

Led By David Crowley, MD

Research Sponsored by Veyl Ventures LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 22, day 28, day 50

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include digestive issues due to dietary changes but specifics aren’t listed in the provided information. Safety will be monitored by recording any adverse events that occur during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 22, day 28, day 50

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 22, day 28, day 50

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 22, day 28, day 50 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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 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 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.

+1 more

Other study objectives

Red blood cell (RBC) indices at screening, day 22, and day 50 following the bone broth diet.

White blood cell count (WBC) with differentials at screening, day 22, and day 50 following the bone broth diet.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dr. Kellyann's Bone BrothExperimental Treatment1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common weight loss treatments, such as the Bone Broth Diet, primarily work by creating a caloric deficit, which encourages the body to burn stored fat for energy. These nutritional interventions often include low-calorie, nutrient-dense foods that promote satiety and reduce overall caloric intake. Some diets may also incorporate elements that improve metabolic health, such as balanced macronutrient distribution and anti-inflammatory ingredients. Understanding these mechanisms is important for weight loss patients as it helps them select effective and sustainable dietary plans that support their long-term health and weight management goals.