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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fruit and Vegetable Juice Concentrate (FVJC)
Placebo
Sponsored by
Nemours Children's Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Nutrition, Oxidative Stress, Insulin Resistance, Whole Food Supplement, Pediatric, Retinoids, Antioxidants, Dietary Supplements

Eligibility Criteria

6 Years - 10 Years (Child)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Nemours Children's Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Overweight

Lean

Arm Description

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

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

Outcomes

Primary Outcome Measures

Beta-carotene Levels Between Overweight and Lean Boys at 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
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.

Secondary Outcome Measures

Full Information

First Posted
February 11, 2009
Last Updated
July 16, 2013
Sponsor
Nemours Children's Clinic
Collaborators
NSA, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00842543
Brief Title
Fruit and Vegetable Juice Concentrate Effects on RBP4 and Antioxidant Capacity in Lean and Overweight 6-10 Year Old Boys
Acronym
FVJC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic
Collaborators
NSA, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Nutrition, Oxidative Stress, Insulin Resistance, Whole Food Supplement, Pediatric, Retinoids, Antioxidants, Dietary Supplements

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Overweight
Arm Type
Experimental
Arm Description
Overweight Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months
Arm Title
Lean
Arm Type
Experimental
Arm Description
Lean Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Fruit and Vegetable Juice Concentrate (FVJC)
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.
Primary Outcome Measure Information:
Title
Beta-carotene Levels Between Overweight and Lean Boys at Baseline
Description
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.
Time Frame
Baseline
Title
Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys
Description
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.
Time Frame
Baseline and 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atilio Canas, MD
Organizational Affiliation
Nemours Children's Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22381025
Citation
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.
Results Reference
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Fruit and Vegetable Juice Concentrate Effects on RBP4 and Antioxidant Capacity in Lean and Overweight 6-10 Year Old Boys

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