Fruit and Vegetable Juice Concentrate Effects on RBP4 and Antioxidant Capacity in Lean and Overweight 6-10 Year Old Boys

Study Overview
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Brief Summary
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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.

Official Title
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Effects Of A Fruit And Vegetable Juice Concentrate (FVJC) In-Vivo On Retinol Binding Protein 4 And Antioxidant Capacity In Normal And Overweight Boys -A Pilot Randomized Placebo Controlled Study

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Fruit and Vegetable Juice Concentrate (FVJC)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6-10 year old healthy boys Lean or overweight Have not started puberty Exclusion Criteria: Chronic illness, asthma, or GI disorder Vegan Diet Use of routine medications or vitamins 4 weeks before study

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Overweight<br>Overweight Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months | Dietary Supplement: Fruit and Vegetable Juice Concentrate (FVJC)<br>* Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.<br>Dietary Supplement: Placebo<br>* Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.<br>|
| Experimental: Lean<br>Lean Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months | Dietary Supplement: Fruit and Vegetable Juice Concentrate (FVJC)<br>* Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.<br>Dietary Supplement: Placebo<br>* Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Oxidative Stress, Insulin Resistance, Whole Food Supplement, Pediatric, Retinoids, Antioxidants, Dietary Supplements