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NCT03659695 · ClinicalTrials.gov registry record · NA
Cardioprotective Effects of Freeze Dried Grape Powder on Blood Pressure and Plasma Lipids/Lipoproteins
A NA study, sponsored by University of Arizona.
- Terminated
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT03659695: Clinical Trial NA study, sponsored by University of Arizona.
NCT03659695 is a NA study that was terminated before completion, run by University of Arizona. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03659695, a NA study, was terminated before completion, sponsored by University of Arizona.
- TERMINATED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Grape Powder
- DIETARY_SUPPLEMENT Placebo Powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-04-01 |
| Est. Completion | 2024-02-13 |
| Phase | NA |
Why NCT03659695 stopped before completion
NCT03659695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Grape Powder is the first listed.
NCT03659695 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03659695 about?
NCT03659695 is a clinical study titled "Cardioprotective Effects of Freeze Dried Grape Powder on Blood Pressure and Plasma Lipids/Lipoproteins". 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 cardiome...
What is the current status of trial NCT03659695?
This trial is currently terminated. It is a NA study. The enrollment target is 16 participants. The study started on 2020-04-01. Estimated completion is 2024-02-13.
What interventions are being tested in trial NCT03659695?
The interventions under investigation include: Grape Powder (DIETARY_SUPPLEMENT), Placebo Powder (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03659695?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03659695's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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