Effects of Juice Plus+® Supplementation on Endothelial Function in Overweight Men

NCT ID: NCT01533987

Last Updated: 2012-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-08-31

Brief Summary

The purpose of the study is to determine the effects of daily ingestion of Juice Plus+® capsules containing Orchard, Garden and Vineyard blends on endothelial function and biomarkers of oxidative stress (oxidized LDL, lipid hydroperoxides and protein carbonyls) in overweight men as compared to the placebo group.

Detailed Description

The prevalence of obesity in both adults and children in the United States has increased significantly over the past 50 years. More than 66% of adults in the US are now overweight or obese and at least 17% of children in the population at large are now considered overweight. Obesity may be a factor predisposing patients to a myriad of different comorbidities that increase the associated mortality rate. Several large prospective trials have documented that obesity is an independent risk factor for all-cause mortality from cardiovascular disease (CVD). Considering the major metabolic and biochemical changes that occur in obesity, such as atherogenic dyslipidemia, insulin resistance and hyperinsulinemia, endothelial dysfunction, and chronic inflammatory and prothrombotic states, obesity plays a role in the pathogenesis of systemic atherosclerosis and its clinical complications. Antioxidants are thought to help preserve the endothelium's capacity to generate NO, which acts to promote vasodilation, stabilize platelets, and promote the anti-inflammatory abilities of the endothelium. Juice Plus+® Capsules containing Orchard, Garden and Vineyard blends are rich in the traditional antioxidants β-carotene, Vitamin E and Vitamin C along with other carotenoids and phytonutrients. There is increasing attention to the possibility that micronutrients may exert health effects in concert. Outcomes in studies of isolated micronutrients, such as vitamin E, have often been often disappointing. Plant-derived micronutrients have the potential to contribute to vascular health by offering the endothelium protection from oxidative stress. Evidence of this anticipated effect would have implications for strategies to prevent or retard cardiovascular disease. Endothelial function testing using high-frequency ultrasound imaging of the brachial artery to assess endothelium-dependent flow-mediated dilatation (FMD) offers a non-invasive, uniquely valuable means of assessing aggregated influences on cardiac risk by gauging a physiologic response of the vascular endothelium. Proposed, therefore, is a randomized, double-blinded and placebo-controlled clinical trial of Juice Plus+® on endothelial function in overweight men with central adiposity.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Juice Plus

Juice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend.

Group Type: EXPERIMENTAL

Juice Plus

Intervention Type: DIETARY_SUPPLEMENT

Juice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend.

Placebo

The placebo consists of microcrystalline cellulose,dicalcium phosphate, magnesium stearate, and FD \& C yellow #6.

Group Type: PLACEBO_COMPARATOR

Juice Plus

Intervention Type: DIETARY_SUPPLEMENT

Juice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend.

Interventions

Juice Plus

Juice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Male age 25-75 years

2. Healthy (no known diabetes mellitus, cardiovascular disease, or eating disorder)

3. Non-smoker

4. Overweight (BMI ≥25) with central adiposity as indicated by waist circumference (≥102 cm).

5. Endothelial dysfunction with high-fat meal

Exclusion Criteria

1. Use of lipid-lowering or antihypertensive medications, unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to EF scanning;

2. Regular use of multivitamins and/or complementary or alternative supplement therapy (including all Juice Plus+® products) and unwillingness to discontinue supplementation for at least 8 weeks prior to study initiation and for study duration

3. Anticipated inability to complete or comply with study protocol;

4. Diagnosed eating disorder

5. Any rheumatologic disease requiring regular use of NSAIDs or alternative medications

6. Regular use of fiber supplements

7. Use of insulin, glucose sensitizing medication, or vasoactive medication

8. Substance abuse (chronic alcoholism, or other chemical dependency

9. Pre-existing cardiovascular disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

NSA, LLC

INDUSTRY

Sponsor Role: collaborator

Griffin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yale Griffin Prevention Research Center

Principal Investigators

David L Katz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Yale-Griffin Prevention Research Center

Locations

Yale-Griffin Prevention Research Center

Derby, Connecticut, United States

Countries

United States

Other Identifiers

2009-06

Identifier Type: -

Identifier Source: org_study_id