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
  Purpose

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.


Condition Intervention
Overweight and Obesity
Dietary Supplement: Juice Plus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Juice Plus+® Supplementation on Endothelial Function in Overweight Men: A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Griffin Hospital:

Primary Outcome Measures:
  • Endothelial Function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Brachial artery flow mediated dilation (FMD)


Secondary Outcome Measures:
  • 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)


Enrollment: 70
Study Start Date: July 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Juice Plus
Juice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend.
Dietary Supplement: Juice Plus
Juice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend.
Placebo Comparator: Placebo
The placebo consists of microcrystalline cellulose,dicalcium phosphate, magnesium stearate, and FD & C yellow #6.
Dietary Supplement: Juice Plus
Juice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533987

Locations
United States, Connecticut
Yale-Griffin Prevention Research Center
Derby, Connecticut, United States, 06418
Sponsors and Collaborators
Griffin Hospital
NSA, LLC
Investigators
Principal Investigator: David L Katz, MD, MPH Yale-Griffin Prevention Research Center
  More Information

No publications provided

Responsible Party: David L. Katz, Yale Griffin Prevention Research Center
ClinicalTrials.gov Identifier: NCT01533987     History of Changes
Other Study ID Numbers: 2009-06
Study First Received: August 9, 2011
Last Updated: February 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Griffin Hospital:
Male
Overweight
Juice Plus

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014