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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)

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
  Purpose

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.


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

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nemours Children's Clinic:

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

Estimated Enrollment: 40
Study Start Date: August 2008
Estimated Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Overweight Boys
30 overweight boys
 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.
Experimental: Normal Weight Boys
10 normal weight boys
 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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842543

Locations
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
NSA, LLC
Investigators
Principal Investigator: Atilio Canas, MD Nemours Children's Clinic
  More Information

No publications provided by Nemours Children's Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: J. Atilio Canas MD, Nemours Children's Clinic, Jacksonville Fl.
ClinicalTrials.gov Identifier: NCT00842543     History of Changes
Other Study ID Numbers: 1607330001
Study First Received: February 11, 2009
Last Updated: March 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Nemours Children's Clinic:
Nutrition
Oxidative Stress
Insulin Resistance
Whole Food Supplement
 Pediatric
Retinoids
Antioxidants
Dietary Supplements

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013