Fruit and Vegetable Juice Concentrate Effects on RBP4 and Antioxidant Capacity in Lean and Overweight 6-10 Year Old Boys (FVJC)
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ClinicalTrials.gov Identifier: NCT00842543 |
Recruitment Status :
Completed
First Posted : February 12, 2009
Results First Posted : September 26, 2013
Last Update Posted : September 26, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Dietary Supplement: Fruit and Vegetable Juice Concentrate (FVJC) Dietary Supplement: Placebo | Not Applicable |
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 |

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
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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
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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. |
- 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.
- 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 |
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

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
United States, Florida | |
Nemours Children's Clinic | |
Jacksonville, Florida, United States, 32207 |
Principal Investigator: | Atilio Canas, MD | Nemours Children's Clinic |
Publications of Results:
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 |
Nutrition Oxidative Stress Insulin Resistance Whole Food Supplement |
Pediatric Retinoids Antioxidants Dietary Supplements |
Overweight Body Weight |