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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, day 56
Awards & highlights
Study Summary
This trial tests how safe and effective a bone broth diet is for weight loss in obese adults. It measures safety, weight, and BMI at two points.
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.Check my eligibility
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.See study design
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, day 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 22, day 28, day 50, day 56
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The change in body mass index (BMI) from baseline at Days 22 and 50 following the bone broth diet.
The change in weight from baseline at Days 22 and 50 following the bone broth diet.
Secondary outcome measures
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 arm circumference from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.
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.
+17 moreOther outcome measures
Blood pressure (BP) at screening, baseline, day 22, day 28, and day 50 following the bone broth diet.
Creatinine measurement at screening, day 22, and day 50 following the bone broth diet.
Estimated glomerular filtration rate (eGFR) at screening day 22, and day 50 following the bone broth diet.
+26 moreTrial 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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Who is running the clinical trial?
Veyl Ventures LLCLead Sponsor
KGK Science Inc.Industry Sponsor
78 Previous Clinical Trials
6,060 Total Patients Enrolled
David Crowley, MDPrincipal InvestigatorKGK Science Inc.
35 Previous Clinical Trials
2,653 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been using tobacco products regularly within the past 6 months and plan to continue using them during the study.You have had problems with alcohol or drugs in the past year.Your body mass index (BMI) is between 30 and 39.9, which means you may be overweight or have obesity.You have or had serious problems with your digestive system.You are currently using medical cannabis products.You are allergic, sensitive, or intolerant to any of the ingredients in the experimental medication.You have had a painful episode of gout in the last year.You have obesity caused by medical conditions or hormonal disorders that affect your metabolism, as determined by a specific assessment.You currently have or have had problems with eating, like anorexia or bulimia, as determined by a special questionnaire.You have had gastric bypass surgery or other weight loss surgeries.You have ongoing long-term inflammation in your body, as determined by a medical assessment.You have cancer, except for a type called skin basal cell carcinoma that was removed completely without needing chemotherapy or radiation. If you have been cancer-free for over five years, you can still participate.
Research Study Groups:
This trial has the following groups:- Group 1: Dr. Kellyann's Bone Broth
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are those aged 55 and over being accepted into the study?
"This research requires that patients be between the ages of 35 and 65 in order to qualify. If an individual is younger than 18, there are 51 trials available for them; if someone is older than 65, then 199 studies could fit their needs."
Answered by AI
Are there still openings in this clinical trial for participants?
"The clinical trial is currently recruiting, as seen on the data hosted on clinicaltrials.gov. The trial was published for public view on January 27th, 2023 and most recently updated February 13th of the same year."
Answered by AI
How many participants are currently receiving treatment in this research project?
"Affirmative. According to data published on clinicaltrials.gov, this research trial is currently looking for volunteers and commenced recruitment on January 27th 2023; its most recent update was February 13th 2023. The study seeks 100 individuals at a single location."
Answered by AI
Do I fulfill the criteria for participation in this medical experiment?
"This clinical trial seeks 100 people aged 35 to 65 who are struggling with weight loss. For eligibility, both male and female participants must have a Body Mass Index between 30.0 and 39.9 kg/m2; females of child-bearing age need to use contraception or be post-menopausal for at least 1 year prior to screening; non-heterosexuals need to use contraceptives if planning on changing partners; vasectomized males should wait 6 months before enrolling in the study."
Answered by AI
Who else is applying?
What site did they apply to?
KGK Science Inc.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’ve been obese for as long as I can remember and sure could use some help.
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Email
Most responsive sites:
- KGK Science Inc.: < 24 hours
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