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Clinical Trials/NCT03659695
NCT03659695TerminatedNot Applicable

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

University of Arizona1 site in 1 country16 target enrollmentStarted: April 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
16
Locations
1
Primary Endpoint
LDL-C/non-HDL-C

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
30 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Grape Powder

Experimental

69 g/d freeze dried grape powder

Intervention: Grape Powder (Dietary Supplement)

Placebo powder

Placebo Comparator

69 g/d placebo powder matched for taste and appearance

Intervention: Placebo Powder (Dietary Supplement)

Outcomes

Primary Outcomes

LDL-C/non-HDL-C

Time Frame: 6-8 weeks

Brachial and central blood pressure

Time Frame: 6-8 weeks

systolic and diastolic pressures

Secondary Outcomes

  • Other lipids and lipoproteins(6-8 weeks)
  • Glucose(6-8 weeks)
  • Augmentation Index(6-8 weeks)
  • Pulse Wave Velocity (PWV)(6-8 weeks)
  • Insulin(6-8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ann Skulas-Ray

Assistant Professor of Nutritional Sciences

University of Arizona

Study Sites (1)

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