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

Nemours Children's Health

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Fruit and Vegetable Juice Concentrate (FVJC); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00842543

1607330001

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: Male

Ages: 6 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 2 patient groups

Overweight

Experimental group

Description:

Overweight Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months

Treatment:

Dietary Supplement: Fruit and Vegetable Juice Concentrate (FVJC)

Dietary Supplement: Placebo

Lean

Experimental group

Description:

Lean Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months

Treatment:

Dietary Supplement: Fruit and Vegetable Juice Concentrate (FVJC)

Dietary Supplement: Placebo