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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00842543
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : September 26, 2013
Last Update Posted : September 26, 2013
Sponsor:
Collaborator:
NSA, LLC
Information provided by (Responsible Party):
Jose Atilio Canas, MD, Nemours Children's Clinic

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Fruit and Vegetable Juice Concentrate (FVJC) Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842543


Locations
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United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
NSA, LLC
Investigators
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Principal Investigator: Atilio Canas, MD Nemours Children's Clinic
Additional Information:
Publications of Results:
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Responsible Party: Jose Atilio Canas, MD, Principal Investigator, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT00842543    
Other Study ID Numbers: 1607330001
First Posted: February 12, 2009    Key Record Dates
Results First Posted: September 26, 2013
Last Update Posted: September 26, 2013
Last Verified: July 2013
Keywords provided by Jose Atilio Canas, MD, Nemours Children's Clinic:
Nutrition
Oxidative Stress
Insulin Resistance
Whole Food Supplement
Pediatric
Retinoids
Antioxidants
Dietary Supplements
Additional relevant MeSH terms:
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Overweight
Body Weight