N/A
N=39
Fruit and Vegetable Juice Concentrate Effects on RBP4 and Antioxidant Capacity in Lean and Overweight 6-10 Year Old Boys
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00842543 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Beta-carotene Levels Between Overweight and Lean Boys at Baseline — 0.22; 0.29 mM/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fruit and Vegetable Juice Concentrate (FVJC) (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Pediatric · 6+ yrs
- Sex
- Male
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Aug 2011
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 | — |
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.
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
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.