Trial Outcomes & Findings for Fruit and Vegetable Juice Concentrate Effects on RBP4 and Antioxidant Capacity in Lean and Overweight 6-10 Year Old Boys (NCT NCT00842543)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

Baseline

Results posted on

2013-09-26

Participant Flow

Participants recruited from pediatric endocrinology clinics, in Jacksonville, USA between July 2008 and December 2009.

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.

Participant milestones

Participant milestones
Measure	Overweight FVJC Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.	Lean FVJC Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.	Overweight Placebo Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.	Lean Placebo Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months
Overall Study STARTED	13	5	13	8
Overall Study COMPLETED	11	5	10	4
Overall Study NOT COMPLETED	2	0	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Overweight FVJC Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.	Lean FVJC Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.	Overweight Placebo Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.	Lean Placebo Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months
Overall Study Withdrawal by Subject	2	0	3	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overweight FVJC n=13 Participants Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.	Lean FVJC n=5 Participants Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.	Overweight Placebo n=13 Participants Overweight Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.	Lean Placebo n=8 Participants Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	13 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants	8 Participants n=4 Participants	39 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age Continuous	8.73 years STANDARD_DEVIATION 1.44 • n=5 Participants	9.48 years STANDARD_DEVIATION 1.17 • n=7 Participants	9.35 years STANDARD_DEVIATION 1.41 • n=5 Participants	9.28 years STANDARD_DEVIATION 1.48 • n=4 Participants	9.145 years STANDARD_DEVIATION 1.39 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants	8 Participants n=4 Participants	39 Participants n=21 Participants
Region of Enrollment United States	13 participants n=5 Participants	5 participants n=7 Participants	13 participants n=5 Participants	8 participants n=4 Participants	39 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Overweight n=26 Participants Overweight boys prior to receiving intervention.	Lean n=9 Participants Lean boys prior to receiving intervention.	Overweight Placebo Reesults displayed for overweight boys who received 6 months of Placebo intervention	Lean Placebo
Beta-carotene Levels Between Overweight and Lean Boys at Baseline	0.22 mM/L Inter-Quartile Range 0.16-0.36 • Interval 0.12 to 0.26	0.29 mM/L Inter-Quartile Range 0.12-0.26 • Interval 0.16 to 0.36	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Overweight n=11 Participants Overweight boys prior to receiving intervention.	Lean n=5 Participants Lean boys prior to receiving intervention.	Overweight Placebo n=10 Participants Reesults displayed for overweight boys who received 6 months of Placebo intervention	Lean Placebo n=4 Participants
Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys	334 Percent Change Standard Error 57	303 Percent Change Standard Error 85	-30 Percent Change Standard Error 57	23 Percent Change Standard Error 94

Adverse Events

Overweight FVJC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lean FVJC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Overweight Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lean Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

J. Atilio Canas MD

Nemours Children's Clinic

Phone: 9046973600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place