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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Fruit and Vegetable Juice Concentrate (FVJC); Dietary Supplement: Placebo

• Registration Number: NCT00842543
• Lead Sponsor: Nemours Children's Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2012-05-18
• Status Verified: 2013-07
• Results First Submitted QC: 2013-07-16
• Last Update Submitted: 2013-07-16
• Results First Posted: 2013-09-26
• Last Update Posted: 2013-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 39

Inclusion Criteria

• 6-10 year old healthy boys
• Lean or overweight
• Have not started puberty

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Exclusion Criteria

• Chronic illness, asthma, or GI disorder
• Vegan Diet
• Use of routine medications or vitamins 4 weeks before study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Overweight	Fruit and Vegetable Juice Concentrate (FVJC)	Overweight Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months
Overweight	Placebo	Overweight Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months
Lean	Fruit and Vegetable Juice Concentrate (FVJC)	Lean Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months
Lean	Placebo	Lean Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months

Primary Outcome Measures

Name	Time	Method
Beta-carotene Levels Between Overweight and Lean Boys at Baseline	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.
Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys	Baseline and 6 months	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.

Trial Locations

Locations (1)

Nemours Children's Clinic; 🇺🇸 Jacksonville, Florida, United States