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

NCT01533987 | Completed

• 1 other identifier: 2009-06
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Male; Overweight; Juice Plus

Outcome Measures

Primary Outcomes (1)

• Endothelial Function

  Brachial artery flow mediated dilation (FMD)

  8 weeks

Secondary Outcomes (4)

• Weight

  8 weeks

• Waist Circumference

  8 weeks

• Blood pressure

  8 weeks

• Serum biomarker measures

  8 weeks

Study Arms (2)

Juice Plus

EXPERIMENTAL

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

Dietary Supplement: Juice Plus

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Juice Plus

Interventions

Juice Plus DIETARY_SUPPLEMENT

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

Juice Plus; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male age 25-75 years
• Healthy (no known diabetes mellitus, cardiovascular disease, or eating disorder)
• Non-smoker
• Overweight (BMI ≥25) with central adiposity as indicated by waist circumference (≥102 cm).
• Endothelial dysfunction with high-fat meal

You may not qualify if:

• 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;
• 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
• Anticipated inability to complete or comply with study protocol;
• Diagnosed eating disorder
• Any rheumatologic disease requiring regular use of NSAIDs or alternative medications
• Regular use of fiber supplements
• Use of insulin, glucose sensitizing medication, or vasoactive medication
• Substance abuse (chronic alcoholism, or other chemical dependency
• Pre-existing cardiovascular disease.

Sponsors & Collaborators

• Griffin Hospital: lead
• NSA, LLC: collaborator

Study Sites (1)

Yale-Griffin Prevention Research Center

Derby, Connecticut, 06418, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David L Katz, MD, MPH

  Yale-Griffin Prevention Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: February 16, 2012
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 16, 2012

Record last verified: 2011-08

Locations

US (1)