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

• Sponsor: Nemours Children's Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00842543
• Collaborator: NSA, LLC (Industry)
• Enrollment: 39
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 1.1

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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: Jul 1, 2008
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 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 [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 [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

Criteria

• Ages Eligible for Study: 6 Years to 10 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Jose Atilio Canas, MD, Principal Investigator, Nemours Children's Clinic
• ClinicalTrials.gov Identifier: NCT00842543
• Other Study ID Numbers: 1607330001
• First Posted: Feb 12, 2009
• Last Update Posted: Sep 26, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Jose Atilio Canas, MD, Principal Investigator, Nemours Children's Clinic: Nutrition; Oxidative Stress; Insulin Resistance; Whole Food Supplement; Pediatric; Retinoids; Antioxidants; Dietary Supplements
• Additional relevant MeSH terms: Overweight

Study Results

Participant Flow

Recruitment Details	Participants recruited from pediatric endocrinology clinics, in Jacksonville, USA between July 2008 and December 2009.
Pre-assignment Detail	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.

Arm/Group Title	Overweight FVJC	Lean FVJC	Overweight Placebo	Lean Placebo
Arm/Group Description	Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.	Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.	Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.	Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months
Period Title: Overall Study
STARTED	13	5	13	8
COMPLETED	11	5	10	4
NOT COMPLETED	2	0	3	4

Baseline Characteristics

Arm/Group Title	Overweight FVJC	Lean FVJC	Overweight Placebo	Lean Placebo	Total
Arm/Group Description	Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.	Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.	Overweight Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.	Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.	Total of all reporting groups
Overall Participants	13	5	13	8	39
Age (Count of Participants)
<=18 years	13 100%	5 100%	13 100%	8 100%	39 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.73 (1.44)	9.48 (1.17)	9.35 (1.41)	9.28 (1.48)	9.145 (1.39)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%
Male	13 100%	5 100%	13 100%	8 100%	39 100%
Region of Enrollment (participants) [Number]
United States	13 100%	5 100%	13 100%	8 100%	39 100%

Outcome Measures

1. Primary Outcome

Title	Beta-carotene Levels Between Overweight and Lean Boys at Baseline
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overweight	Lean
Arm/Group Description	Overweight boys prior to receiving intervention.	Lean boys prior to receiving intervention.
Measure Participants	26	9
Median (Inter-Quartile Range) [mM/L]	0.22 (0.16-0.36)	0.29 (0.12-0.26)

2. Primary Outcome

Title	Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys
Description	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.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overweight FVJC	Lean FVJC	Overweight Placebo	Lean Placebo
Arm/Group Description	Results displayed for overweight boys who received 6 months of FVJC intervention	Reesults displayed for overweight boys who received 6 months of Placebo intervention
Measure Participants	11	5	10	4
Least Squares Mean (Standard Error) [Percent Change]	334 (57)	303 (85)	-30 (57)	23 (94)

Adverse Events

Arm/Group Title	Overweight FVJC		Lean FVJC		Overweight Placebo		Lean Placebo
Arm/Group Description	Overweight Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.		Lean Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.		Overweight Boys receiving Placebo, 1 capsule, twice a day, for 6 months.		Lean Boys receiving Placebo, 1 capsule, twice a day, for 6 months.
All Cause Mortality
	Overweight FVJC		Lean FVJC		Overweight Placebo		Lean Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Overweight FVJC		Lean FVJC		Overweight Placebo		Lean Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/5 (0%)		0/13 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Overweight FVJC		Lean FVJC		Overweight Placebo		Lean Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/5 (0%)		0/13 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.