NCT01775748

Brief Summary

The study will compare Concord grape juice to a beverage that contains no grape flavonoids, but has a similar appearance and taste (placebo juice). A total of 60 overweight and obese participants over age 50 will be enrolled. Each participant will drink each beverage for 4 weeks with a 2-week rest period between two beverage consumption periods. The order of beverages (grape juice first or placebo juice first) will be randomized. The investigators will use ultrasound to measure brachial artery flow-mediated dilation, a measure of endothelial vasodilator function. The investigators will also collect blood samples to further assess the cardiovascular effects of grape juice. The aim of the study is to determine whether Concord grape juice improves endothelial function in patients at risk who do not have cardiovascular disease and may provide information that would guide dietary recommendations. The results may also be used by the sponsor to substantiate claims and labeling of their product.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2014

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

January 23, 2013

Last Update Submit

February 9, 2018

Conditions

ObesityOverweight

Keywords

Grape juice

Outcome Measures

Primary Outcomes (1)

  • Brachial artery flow mediated dilation

    Endothelial function will be assessed as brachial artery flow-mediated dilation using vascular ultrasound

    4 weeks

Secondary Outcomes (3)

  • Nitroglycerin-mediated dilation

    4 weeks

  • Carotid-Femoral Pulse Wave Velocity

    4 weeks

  • Reactive hyperemia

    4 weeks

Other Outcomes (1)

  • Fasting glucose and insulin

    4 weeks

Study Arms (2)

Active First

OTHER

Active Concord Grape Juice 12 oz per day Placebo Grape Juice 12 oz per day

Other: Active Concord Grape Juice 12 oz per dayOther: Placebo Grape Juice 12 oz per day

Placebo First

OTHER

Placebo Grape Juice 12 oz per day Active Concord Grape Juice 12 oz per day

Other: Active Concord Grape Juice 12 oz per dayOther: Placebo Grape Juice 12 oz per day

Interventions

Active Concord Grape Juice 12 oz per dayOTHER

Grape Juice 12 oz per day

Active FirstPlacebo First
Placebo Grape Juice 12 oz per dayOTHER

Placebo Grape Juice 12 oz per day

Active FirstPlacebo First

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index ≥ 25 and \< 40 kg/m2
  • Age ≥ 50 years
  • Otherwise healthy

You may not qualify if:

  • Clinical diagnosis of atherosclerotic vascular disease.
  • Clinical history of diabetes mellitus or fasting glucose ≥126 mg/dl
  • Uncontrolled hypertension
  • Treatment with an investigational new drug within the last 30 days
  • Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, or other conditions that in the opinion of the principal investigator make the study inappropriate
  • Psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study
  • Use of Vitamin E, Vitamin C, beta carotene, lipoic acid, or other food or herbal supplements within 1 month of enrollment. Subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the recommended daily allowance will not be excluded
  • Extreme dietary habits (i.e. Atkins, very high protein/low carbohydrate, or vegan diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert E Eberhardt, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 25, 2013

Study Start

January 1, 2013

Primary Completion

March 19, 2014

Study Completion

March 19, 2014

Last Updated

February 12, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)