Cardioprotective Effects of Freeze Dried Grape Powder on Blood Pressure and Plasma Lipids/Lipoproteins

February 13, 2024 updated by: Ann Skulas-Ray, University of Arizona

Cardioprotective Effects of Freeze Dried Grape Powder Supplementation on Blood Pressure and Plasma Lipids/Lipoproteins: A Pilot Study

Whole food-based dietary interventions have the potential to promote cardiometabolic health via multiple mechanisms, including improvements in blood pressure, bad cholesterol, and other markers of metabolic health. Previous research suggests that grapes have the potential to promote optimal cardiometabolic function by reducing LDL-C, but it remains unclear whether there is a dose-response relationship. Moreover, few studies have evaluated effects on vascular health following daily grape consumption. We propose to examine the effects of 6-8 weeks of supplementation with freeze dried grape powder (69 g/d; ~three ¾ cup servings) compared to a control powder without grapes on: 1) bad cholesterol and blood pressure and 2) other measures of cardiometabolic health, including glucose and insulin. We will enroll overweight (BMI 25-36 kg/m2) but otherwise healthy adults with moderately elevated LDL-C (>115 mg/dL for women and >130 mg/dL for men) and/or blood pressure of120-159/80-99 mm Hg. This will optimize the potential for observing significant changes in these measures of health. We will recruit 20 eligible participants with the expectation that at least 15 will complete the study. The placebo-controlled, crossover study design will allow for a direct comparison of effects within the same participant. We anticipate that the bioactive components of grapes will promote cardiometabolic health via changes in LDL-C and blood pressure. Results from the proposed study would help to clarify how daily grape consumption might promote health and would provide further support for incorporating whole, unprocessed fruit in a healthy dietary pattern.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • University of Arizona Agricultural Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI of 25-36 kg/m2

  • At least one of the following:

    • LDL-C above 115 mg/dL (women) or above 130 mg/dL (men)
    • Systolic blood pressure of 120-159 mmHg
    • Diastolic blood pressure of 80-99 mmHg

Exclusion Criteria:

  • Allergies to grapes
  • History of CVD, blood pressure ≥ 160/100 mmHg, kidney disease, diabetes, or inflammatory diseases such as GI disorders and rheumatoid arthritis
  • Use of medications/supplements for elevated lipids, blood pressure, or glucose
  • Chronic use of non-steroidal anti-inflammatory or immunosuppressant drugs
  • Conditions requiring chronic use of steroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Grape Powder
69 g/d freeze dried grape powder
Dietary supplement: Grape Powder
69 g/d freeze dried grape powder
Placebo Comparator: Placebo powder
69 g/d placebo powder matched for taste and appearance
Dietary supplement: Placebo Powder
69 g/d placebo powder matched for taste and appearance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL-C/non-HDL-C
Time Frame: 6-8 weeks
6-8 weeks
Brachial and central blood pressure
Time Frame: 6-8 weeks
systolic and diastolic pressures
6-8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Augmentation Index
Time Frame: 6-8 weeks
augmentation index corrected for heart rate
6-8 weeks
Pulse Wave Velocity (PWV)
Time Frame: 6-8 weeks
6-8 weeks
Other lipids and lipoproteins
Time Frame: 6-8 weeks
HDL-C, total cholesterol, and triglycerides
6-8 weeks
Glucose
Time Frame: 6-8 weeks
fasting blood glucose
6-8 weeks
Insulin
Time Frame: 6-8 weeks
fasting blood insulin
6-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

February 13, 2024

Study Completion (Actual)

February 13, 2024

Study Registration Dates

First Submitted

September 2, 2018

First Submitted That Met QC Criteria

September 2, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Grape Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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