N/A Completed N=39 Randomized Quadruple-blind Prevention

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

Obesity

Source: ClinicalTrials.gov NCT00842543 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2013

Primary outcomePrimary: Beta-carotene Levels Between Overweight and Lean Boys at Baseline — 0.22; 0.29 mM/L

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Beta-carotene Levels Between Overweight and Lean Boys at Baseline	0.22; 0.29	—
PRIMARY Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys	334; 303; -30; 23	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00842543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.