Clinical Trials Directory

Trials / Terminated

TerminatedNCT03659695

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

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
16 (actual)
Sponsor
University of Arizona · Academic / Other
Sex
All
Age
30 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTGrape Powder69 g/d freeze dried grape powder
DIETARY_SUPPLEMENTPlacebo Powder69 g/d placebo powder matched for taste and appearance

Timeline

Start date
2020-04-01
Primary completion
2024-02-13
Completion
2024-02-13
First posted
2018-09-06
Last updated
2024-02-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03659695. Inclusion in this directory is not an endorsement.