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

NCT ID: NCT00842543

Last Updated: 2013-09-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-08-31

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.

Detailed Description

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Conditions

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Obesity

Keywords

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Nutrition Oxidative Stress Insulin Resistance Whole Food Supplement Pediatric Retinoids Antioxidants Dietary Supplements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Overweight

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

Group Type EXPERIMENTAL

Fruit and Vegetable Juice Concentrate (FVJC)

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Lean

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

Group Type EXPERIMENTAL

Fruit and Vegetable Juice Concentrate (FVJC)

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Fruit and Vegetable Juice Concentrate (FVJC)

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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NSA, LLC

INDUSTRY

Sponsor Role collaborator

Nemours Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jose Atilio Canas, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Atilio Canas, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Clinic

Locations

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Nemours Children's Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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Canas JA, Damaso L, Altomare A, Killen K, Hossain J, Balagopal PB. Insulin resistance and adiposity in relation to serum beta-carotene levels. J Pediatr. 2012 Jul;161(1):58-64.e1-2. doi: 10.1016/j.jpeds.2012.01.030. Epub 2012 Feb 28.

Reference Type RESULT
PMID: 22381025 (View on PubMed)

Other Identifiers

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1607330001

Identifier Type: -

Identifier Source: org_study_id