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

• 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: Nemours Children's Clinic
• Collaborator: NSA, LLC
• Information provided by (Responsible Party): Jose Atilio Canas, MD, Nemours Children's Clinic

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

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:

Article: Insulin Resistance and Adiposity in Relation to Serum b-Carotene Levels 

Publications of Results:

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. doi: 10.1016/j.jpeds.2012.01.030. Epub 2012 Feb 28.

• 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
• 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:

Overweight; Body Weight