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| Name | Class |
|---|---|
| NSA, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overweight | Experimental | Overweight Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months |
|
| Lean | Experimental | Lean Boys receiving either Fruit and Vegetable Juice Concentrate (FVJC) or Placebo, 1 capsule, twice a day, for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atilio Canas, MD | Nemours Children's Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22381025 | Result | 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. |
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Of the 246 children screened for eligibility, 74 did not meet criteria, 35 refused to participate, 98 were not randomized for various reasons, 39 were randomized.
Participants recruited from pediatric endocrinology clinics, in Jacksonville, USA between July 2008 and December 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overweight FVJC | Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months. |
| FG001 | Lean FVJC | Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months. |
| FG002 | Overweight Placebo | Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months. |
| FG003 | Lean Placebo | Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overweight FVJC | Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months. |
| BG001 | Lean FVJC | Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | mM/L | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overweight FVJC | Overweight Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Atilio Canas MD | Nemours Children's Clinic | 9046973600 | 3674 | jcanas@nemours.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005638 | Fruit |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo | Dietary Supplement | Take FVJC or placebo twice a day for 6 months while receiving dietary and physical activity counseling from a Registered Dietician. |
|
| BG002 | Overweight Placebo | Overweight Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months. |
| BG003 | Lean Placebo | Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline and 6 months |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Lean FVJC | Lean Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months. | 0 | 5 | 0 | 5 |
| EG002 | Overweight Placebo | Overweight Boys receiving Placebo, 1 capsule, twice a day, for 6 months. | 0 | 13 | 0 | 13 |
| EG003 | Lean Placebo | Lean Boys receiving Placebo, 1 capsule, twice a day, for 6 months. | 0 | 8 | 0 | 8 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |