The primary objective of this study is to investigate the safety and efficacy of a bone broth diet on weight loss in obese adults. The change in weight and body mass index (BMI) following the bone broth diet will be measured from baseline at Days 22 and 50. Additionally, the safety and tolerability of the bone broth diet will be measured by the occurrence of post-emergent adverse events (AEs).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Participants will have two bone broth phases, each three weeks in length. Bone broth phases will be separated by a one-week maintenance phase. A one-week maintenance phase will also occur after the second bone broth phase. Each week of a broth phase will consist of five feeding days and five fasting days. On feeding days, participants will consume one packet of bone broth, twice each day, as snacks between meals. On fasting days, participants will consume one packet of bone broth every two hours for a total of seven packets each day.
KGK Science Inc.
London, Ontario, Canada
The change in weight from baseline at Days 22 and 50 following the bone broth diet.
Time frame: baseline, day 22, day 50
The change in body mass index (BMI) from baseline at Days 22 and 50 following the bone broth diet.
Time frame: baseline, day 22, day 50
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.
Time frame: baseline, day 22, day 28, day 50, 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.
Time frame: baseline, day 22, day 28, day 50, day 56
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 android/gynoid fat ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet as assessed by DEXA measurements.
Time frame: baseline, day 22, day 28, day 50
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 fat mass from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet as assessed by DEXA measurements.
Time frame: baseline, day 22, day 28, day 50
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 muscle mass from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet as assessed by DEXA measurements.
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Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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.
Time frame: baseline, day 22, day 28, day 50
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 quality of life is assessed by the Modified Short Form (SF)-36 Quality of Life Questionnaire from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. The SF-36 measures nine scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and reported health transition. The scores range from 0 to 100 where higher scores indicate a better state of health.
Time frame: baseline, day 22, day 28, day 50