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

NCT00842543 | Completed Results DMC

• 1 other identifier: 1607330001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Nutrition; Oxidative Stress; Insulin Resistance; Whole Food Supplement; Pediatric; Retinoids; Antioxidants; Dietary Supplements

Outcome Measures

Primary Outcomes (2)

• Beta-carotene Levels Between Overweight and Lean Boys at 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.

  Baseline

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

  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.

  Baseline and 6 months

Study Arms (2)

Overweight

EXPERIMENTAL

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); Dietary Supplement: Placebo

Lean

EXPERIMENTAL

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); Dietary Supplement: Placebo

Interventions

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.

Lean; Overweight

Placebo DIETARY_SUPPLEMENT

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

Lean; Overweight

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• year old healthy boys
• Lean or overweight
• Have not started puberty

You may not qualify if:

• Chronic illness, asthma, or GI disorder
• Vegan Diet
• Use of routine medications or vitamins 4 weeks before study

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• NSA, LLC: collaborator

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Related Publications (1)

• Canas JA, Damaso L, Altomare A, Killen K, Hossain J, Balagopal PB. Insulin resistance and adiposity in relation to serum beta-carotene levels. J Pediatr. 2012 Jul;161(1):58-64.e1-2. doi: 10.1016/j.jpeds.2012.01.030. Epub 2012 Feb 28.

  PMID: 22381025 RESULT

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Fruit

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: J. Atilio Canas MD
• Organization: Nemours Children's Clinic

jcanas@nemours.org

9046973600

Study Officials

• Atilio Canas, MD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: July 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 26, 2013
• Results First Posted: September 26, 2013

Record last verified: 2013-07

Locations

US (1)