CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Fruit and Vegetable Juice Concentrate (FVJC) +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00842543
NCT00842543N/ACompleted

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

Nemours Children's Clinic·interventional·Posted Feb 12, 2009·Updated Sep 26, 2013

In Brief

A clinical study evaluating Fruit and Vegetable Juice Concentrate (FVJC) and Placebo for Obesity. Completed, enrolled 39 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
CollaboratorsNSA, LLC

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 12, 2009
Enrollment StartJul 1, 2008
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.4 years ago

Interventions

Fruit and Vegetable Juice Concentrate (FVJC)dietary

Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.

Placebodietary

Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.