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.
Eligible Conditions
- Weight Loss
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 20 Secondary · Reporting Duration: baseline, day 22, day 28, day 50, day 56
baseline to day 50
The incidence of pre-emergent and post-emergent adverse events (AE).
Day 50
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.
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 high-density lipoprotein cholesterol (HDL-C) levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.
The change in hip circumference from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.
The change in low-density cholesterol to high-density cholesterol ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.
The change in low-density lipoprotein cholesterol (LDL-C) levels 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.
The change in non-high-density lipoprotein cholesterol (non-HDL-C) levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.
The change in quality of life from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.
The change in sagittal abdominal diameter (SAD) from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.
The change in thigh circumference from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.
The change in total cholesterol levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.
The change in triglyceride levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.
The change in triglyceride to high-density cholesterol ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.
The change in waist circumference from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.
The change in waist-to-hip ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet.
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.
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.
Day 50
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.
Day 50
Blood pressure (BP) at screening, baseline, day 22, day 28, and day 50 following the bone broth diet.
Heart rate (HR) at screening, baseline, day 22, day 28, and day 50 following the bone broth diet.
Day 50
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.
Hematocrit at screening, day 22, and day 50 following the bone broth diet.
Hemoglobin at screening, day 22, and day 50 following the bone broth diet.
Immature granulocytes at screening, day 22, and day 50 following the bone broth diet.
Measurement of electrolytes (sodium, potassium, chloride) at screening, day 22, and day 50 following the bone broth diet.
Measurement of uric acid at screening, day 22, and day 50 following the bone broth diet.
Nucleated red blood cells (RBC) at screening, day 22, and day 50 following the bone broth diet.
Platelet count at screening, day 22, and day 50 following the bone broth diet.
Red blood cell (RBC) indices at screening, day 22, and day 50 following the bone broth diet.
Red blood cell count (RBC) at screening, day 22, and day 50 following the bone broth diet.
Serum alanine aminotransferase (ALT) measurement at screening, day 22, and day 50 following the bone broth diet.
Serum alkaline phosphatase (ALP) measurement at screening, day 22, and day 50 following the bone broth diet.
Serum aspartate aminotransferase (AST) measurement at screening, day 22, and day 50 following the bone broth diet.
Serum total bilirubin measurement at screening, day 22, and day 50 following the bone broth diet.
Urinalysis-chemistry for blood at screening, day 22, and day 50 following the bone broth diet.
Urinalysis-chemistry for urinary glucose at screening, day 22, and day 50 following the bone broth diet.
Urinalysis-chemistry for urinary ketones at screening, day 22, and day 50 following the bone broth diet.
Urinalysis-chemistry for urinary leukocytes at screening, day 22, and day 50 following the bone broth diet.
Urinalysis-chemistry for urinary nitrite at screening, day 22, and day 50 following the bone broth diet.
Urinalysis-chemistry for urinary pH at screening, day 22, and day 50 following the bone broth diet.
Urinalysis-chemistry for urinary proteins at screening, day 22, and day 50 following the bone broth diet.
Urinalysis-chemistry for urinary specific gravity at screening, day 22, and day 50 following the bone broth diet.
Urine color and appearance at screening, day 22, and day 50 following the bone broth diet.
White blood cell count (WBC) 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.
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Dr. Kellyann's Bone Broth
1 of 1
Experimental Treatment
100 Total Participants · 1 Treatment Group
Primary Treatment: Dr. Kellyann's Bone Broth · No Placebo Group · N/A
Dr. Kellyann's Bone Broth
Other
Experimental Group · 1 Intervention: Dr. Kellyann's Bone Broth · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, day 22, day 28, day 50, day 56
Who is running the clinical trial?
Veyl Ventures LLCLead Sponsor
KGK Science Inc.Industry Sponsor
73 Previous Clinical Trials
5,848 Total Patients Enrolled
David Crowley, MDPrincipal InvestigatorKGK Science Inc.
31 Previous Clinical Trials
2,486 Total Patients Enrolled
Eligibility Criteria
Age 35 - 65 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Your body mass index (BMI) is between 30.0 and 39.9 kg/m2.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer