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

Not Applicable

Terminated

• Conditions: Cardiovascular Risk Factor
• Interventions: Dietary Supplement: Grape Powder; Dietary Supplement: Placebo Powder

• Registration Number: NCT03659695
• Lead Sponsor: University of Arizona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-02
• Study First Submitted QC: 2018-09-02
• Study First Posted: 2018-09-06
• Study Start: 2020-04-01
• Status Verified: 2024-02
• Primary Completion: 2024-02-13
• Study Completion: 2024-02-13
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Grape Powder	Grape Powder	69 g/d freeze dried grape powder
Placebo powder	Placebo Powder	69 g/d placebo powder matched for taste and appearance

Primary Outcome Measures

Name	Time	Method
LDL-C/non-HDL-C	6-8 weeks
Brachial and central blood pressure	6-8 weeks	systolic and diastolic pressures

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Arizona Agricultural Center; 🇺🇸 Tucson, Arizona, United States