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

This study has been completed.
Sponsor:
Collaborator:
NSA, LLC
Information provided by (Responsible Party):
Jose Atilio Canas, MD, Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT00842543
First received: February 11, 2009
Last updated: July 16, 2013
Last verified: July 2013
  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 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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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:


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

Primary Outcome Measures:
  • Beta-carotene Levels Between Overweight and Lean Boys at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 39
Study Start Date: July 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Overweight
Overweight Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months
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.
Dietary Supplement: Placebo
Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.
Experimental: Lean
Lean Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months
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.
Dietary Supplement: Placebo
Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Responsible Party: Jose Atilio Canas, MD, Principal Investigator, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT00842543     History of Changes
Other Study ID Numbers: 1607330001
Study First Received: February 11, 2009
Results First Received: May 18, 2012
Last Updated: July 16, 2013
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 August 20, 2014