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

Overweight and Obesity Clinical Trial

Official title:

Effects of Juice Plus+® Supplementation on Endothelial Function in Overweight Men: A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533987
• Other study ID #: 2009-06
• Status: Completed
• Phase: N/A
• First received: August 9, 2011
• Last updated: February 15, 2012
• Start date: July 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2011
• Source: Griffin Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Juice Plus
Juice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend.

Locations

Country	Name	City	State
United States	Yale-Griffin Prevention Research Center	Derby	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Griffin Hospital	NSA, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function	Brachial artery flow mediated dilation (FMD)	8 weeks	No
Secondary	Weight		8 weeks	No
Secondary	Waist Circumference		8 weeks	No
Secondary	Blood pressure		8 weeks	No
Secondary	Serum biomarker measures	These samples will be used to assess participants' biomarkers of oxidative stress (i.e. oxidized LDL levels, lipid hydroperoxides, and protein carbonyls) and compliance measure (i.e. serum carotenoids)	8 weeks	No