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Effect of Concord Grape Juice on Endothelial Function

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Concord Grape Juice 12 oz per day
Placebo Grape Juice 12 oz per day
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring Grape juice

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Boston University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Active First

Placebo First

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Nitroglycerin-mediated dilation
Non-endothelium-dependent dilation will be assessed by measuring the dilator response to sublingual nitroglycerin using vascular ultrasound
Carotid-Femoral Pulse Wave Velocity
Central aortic stiffness will be assessed as carotid-femoral pulse wave velocity using applanation tonometry
Reactive hyperemia
We will use vascular ultrasound to determine maximal hyperemic flow velocity in the brachial artery induced by 4-minute cuff occlusion.

Full Information

First Posted
January 23, 2013
Last Updated
February 9, 2018
Sponsor
Boston University
Collaborators
Welch's, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01775748
Brief Title
Effect of Concord Grape Juice on Endothelial Function
Official Title
Effect Of Concord Grape Juice On Endothelial Function In Obese And Overweight Individuals Over Age 50
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
March 19, 2014 (Actual)
Study Completion Date
March 19, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
Welch's, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Grape juice

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active First
Arm Type
Other
Arm Description
Active Concord Grape Juice 12 oz per day Placebo Grape Juice 12 oz per day
Arm Title
Placebo First
Arm Type
Other
Arm Description
Placebo Grape Juice 12 oz per day Active Concord Grape Juice 12 oz per day
Intervention Type
Other
Intervention Name(s)
Active Concord Grape Juice 12 oz per day
Intervention Description
Grape Juice 12 oz per day
Intervention Type
Other
Intervention Name(s)
Placebo Grape Juice 12 oz per day
Intervention Description
Placebo Grape Juice 12 oz per day
Primary Outcome Measure Information:
Title
Brachial artery flow mediated dilation
Description
Endothelial function will be assessed as brachial artery flow-mediated dilation using vascular ultrasound
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Nitroglycerin-mediated dilation
Description
Non-endothelium-dependent dilation will be assessed by measuring the dilator response to sublingual nitroglycerin using vascular ultrasound
Time Frame
4 weeks
Title
Carotid-Femoral Pulse Wave Velocity
Description
Central aortic stiffness will be assessed as carotid-femoral pulse wave velocity using applanation tonometry
Time Frame
4 weeks
Title
Reactive hyperemia
Description
We will use vascular ultrasound to determine maximal hyperemic flow velocity in the brachial artery induced by 4-minute cuff occlusion.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Fasting glucose and insulin
Description
Fasting glucose and insulin
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index ≥ 25 and < 40 kg/m2 Age ≥ 50 years Otherwise healthy Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert E Eberhardt, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Concord Grape Juice on Endothelial Function

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