Clinical trial NCT03659695: Cardioprotective Effects of Freeze Dried Grape Powder on Blood Pressure and Plasma Lipids/Lipoproteins
Official title: Cardioprotective Effects of Freeze Dried Grape Powder Supplementation on Blood Pressure and Plasma Lipids/Lipoproteins: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: LDL-C/non-HDL-C
timeFrame: 6-8 weeks
measure: Brachial and central blood pressure
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Pulse Wave Velocity (PWV)
timeFrame: 6-8 weeks
measure: Augmentation Index
timeFrame: 6-8 weeks
measure: Other lipids and lipoproteins
timeFrame: 6-8 weeks
measure: Glucose
timeFrame: 6-8 weeks
measure: Insulin
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Agricultural Center
state: Arizona
Study officials:
References:
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