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Completed

NCT Number: NCT00842543

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

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–10 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fruit and Vegetable Juice Concentrate (FVJC)

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Beta-carotene Levels Between Overweight and Lean Boys at Baseline

    Time frame: 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.

  2. Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys

    Time frame: Baseline and 6 months

    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.

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • NSA, LLC

Registry information

Official study 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

Acronym: FVJC

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 12, 2009
Registry last updated
Sep 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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