Our study aims to evaluate if the consumption of a Fruit and Vegetable Juice Concentrate (FVJC) vs. placebo can exert changes in the serum levels of Retinol Binding Protein 4 (RBP4), carotenoids, tocopherol, antioxidant capacity, pro-inflammatory markers, insulin sensitivity in conjunction with weight management in a cohort of lean as compared to overweight healthy six to ten year-old boys. The boys will undergo a detailed medical and family history and a complete physical examination during the screening visit. Careful anthropometric measures and body composition by DEXA will be performed. Nutritional and exercise counseling will be given at the start of the study. The outcome measures will include differences in serum RBP4, antioxidant levels, inflammatory markers and insulin sensitivity at baseline and six months after consumption of FVJC in a randomized double blind placebo control manner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
39
Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.
Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.
Nemours Children's Clinic
Jacksonville, Florida, United States
Beta-carotene Levels Between Overweight and Lean Boys at Baseline
Value at baseline. Beta-carotene is a component of the body's natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.
Time frame: Baseline
Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys
Value at 6 months minus value at baseline. Beta-carotene is a component of the body's natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.
Time frame: Baseline and 6 months
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