The purpose of this study is to assess the safety and efficacy of a weight management program composed of dietary supplements and a reduced calorie eating program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
141
Supplements to maintain muscle, assist in utilization of body fat, curb appetite, support positive willpower along with TR90 Eating plan. TR90 Eating Plan will consist of approximately 30 g high quality protein along with fruit, vegetables and complex carbohydrates
Utah State University
Logan, Utah, United States
Determine the effect of a novel weight management program on body fat mass over 90 days.
Evaluate changes in body measurements (weight and BMI; arm, waist, hip, thigh, claf, and ankle circumferences) and body composition (fat mass, fat free mass, % body fat) by Dual Energy X-ray Absorptiometry (DEXA) scanner.
Time frame: Days 0 and 90
Determine the safety of novel weight management program (CBC, Comp. metabolic, lipid panel, heart rate, blood pressure and adverse events)
Time frame: Throughout 1 year
Evaluate changes in body measurements (weight and BMI; arm, waist, hip, thigh, claf, and ankle circumferences) and body composition (fat mass, fat free mass, % body fat) by Dual Energy X-ray Absorptiometry (DEXA) scanner.
Time frame: throughout 1 year
Determine subjective measurements of hunger and appetite from standardized questionnaires (IWQOL Hunger/Appetite and overall wellbeing)
Time frame: Throughout 1 year
Determine skin carotenoid (Biophotonic Scanner) measurement changes.
Biophotonic Scanner utilizes raman spectroscopy to determine skin carotenoid concentrations.
Time frame: Throughout 1 year
Evaluate the changes in metabolism and appetite hormone levels from the baseline visit to day 90.
Leptin, Insulin, Adiponectin, Pancreatic Polypeptide, gLP1, C-peptide, Glucagon, Resistin and HbA1c
Time frame: Days 0 and 90
Evaluate the changes in inflammatory markers from the baseline visit to day 90.
hsCRP, IL-6 and TNF Receptors 60 and 80
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Time frame: Days 0 and 90
Evaluate the changes in gene expression from the baseline visit to day 90.
Full gene arrays will be made on peripheral blood mononuclear cells. The gene expression changes will be made at baseline and day 90. There will also be a comparison back to proteins (i.e. hormones and inflammatory markers).
Time frame: Day 0 and 90
Evaluate resting energy expenditure and substrate utilization from baseline to days 90, 180, and 365.
Resting metabolic rate (RMR)and substrate utilization (R-values to determine wheather subjects are utilizing more fats or carbohydrates to meet energy demands) will be measured by CPET Quark.
Time frame: Days 0, 90, 80, and 365