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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2010 by Nemours Children's Clinic.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

NSA, LLC

Information provided by:

Nemours Children's Clinic

ClinicalTrials.gov Identifier:

NCT00842543

First received: February 11, 2009

Last updated: March 11, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 11, 2009

Last Updated Date

March 11, 2010

Start Date ^ICMJE

August 2008

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Decrease RBP4 levels and improved insulin sensitivity in obese individuals. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00842543 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 obese healthy six to ten year-old boys. We hypothesize that elevated RBP4 can serve as a marker for insulin resistance and postulate that consumption of FVJC lowers RBP4 and improves insulin sensitivity in obese individuals regardless of weight loss.

Detailed Description

This study is aimed at better understanding of the relationship between nutrition and obesity-related insulin resistance and oxidative stress in 30 obese and 10 lean otherwise healthy prepubertal boys. They should be free of illness, or have not used any medications or vitamin supplements within 4 weeks of study participation. 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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Dietary Supplement: 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.

Study Arm (s)

Experimental: Overweight Boys
30 overweight boys

Intervention: Dietary Supplement: Fruit and Vegetable Juice Concentrate (FVJC)
Experimental: Normal Weight Boys
10 normal weight boys

Intervention: Dietary Supplement: Fruit and Vegetable Juice Concentrate (FVJC)

Publications *

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

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

6 Years to 10 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00842543

Other Study ID Numbers ^ICMJE

1607330001

Has Data Monitoring Committee

Yes

Responsible Party

J. Atilio Canas MD, Nemours Children's Clinic, Jacksonville Fl.

Study Sponsor ^ICMJE

Nemours Children's Clinic

Collaborators ^ICMJE

NSA, LLC

Investigators ^ICMJE

Principal Investigator:

Atilio Canas, MD

Nemours Children's Clinic

Information Provided By

Nemours Children's Clinic

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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