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

This study has been completed.
Sponsor:
Collaborator:
NSA, LLC
Information provided by:
Griffin Hospital
ClinicalTrials.gov Identifier:
NCT01533987
First received: August 9, 2011
Last updated: February 15, 2012
Last verified: August 2011

August 9, 2011
February 15, 2012
July 2009
July 2010   (final data collection date for primary outcome measure)
Endothelial Function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Brachial artery flow mediated dilation (FMD)
Same as current
Complete list of historical versions of study NCT01533987 on ClinicalTrials.gov Archive Site
  • Weight [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Waist Circumference [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Serum biomarker measures [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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)
Same as current
Not Provided
Not Provided
 
Effects of Juice Plus+® Supplementation on Endothelial Function in Overweight Men
Effects of Juice Plus+® Supplementation on Endothelial Function in Overweight Men: A Randomized, Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Overweight and Obesity
Dietary Supplement: Juice Plus
Juice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend.
  • Experimental: Juice Plus
    Juice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend.
    Intervention: Dietary Supplement: Juice Plus
  • Placebo Comparator: Placebo
    The placebo consists of microcrystalline cellulose,dicalcium phosphate, magnesium stearate, and FD & C yellow #6.
    Intervention: Dietary Supplement: Juice Plus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
August 2010
July 2010   (final data collection date for primary outcome measure)

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.
Male
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01533987
2009-06
No
David L. Katz, Yale Griffin Prevention Research Center
Griffin Hospital
NSA, LLC
Principal Investigator: David L Katz, MD, MPH Yale-Griffin Prevention Research Center
Griffin Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP