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NCT03522974 · ClinicalTrials.gov registry record · NA
Effects of Freeze Dried Strawberry Powder Supplementation on Cardiovascular Risk Factors and Gut Microbiome
A NA study, sponsored by University of Arizona.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT03522974 is a NA study that was terminated before completion, run by University of Arizona. The registered enrollment target is 1 participants.
The verdict
NCT03522974, a NA study, was terminated before completion, sponsored by University of Arizona.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Dietary interventions designed to promote health by increasing the consumption of particular health-promoting foods (e.g., strawberries) generally target blood pressure and LDL-C; however, CVD risk reduction may also be achieved via changes in emerging endpoints such as the gut microbiome. Previous research suggests that strawberries have the potential to reduce LDL-C, but it remains unclear whether there is a dose-response relationship. Moreover, few studies have evaluated effects on vascular health or characterized changes in the gut microbiome following daily strawberry consumption. Additionally, previous studies have largely been conducted among Caucasian populations. Given the demographics of the US, it is important to evaluate effects in study populations that include ethnicities that may have higher risk of type 2 diabetes and/or other CVD risk factors, such as Hispanics. This study aims to examine the effects of 4 weeks of supplementation with two doses of freeze dried strawberry powder (low dose: 13 g/d and high dose: 40 g/d) on: 1) LDL-C and blood pressure; 2) gut microbiome profile; and 3) other CVD and type 2 diabetes risk factors, including glucose, insulin, and inflammatory markers. Overweight (BMI 25-36 kg/m2) but otherwise healthy adults with moderately elevated LDL-C (\>3.0 mmol/L) and/or prehypertension (120-159/80-99 mm Hg) will be enrolled. This will optimize the potential for observing significant benefits on these outcomes. 50 eligible participants will be recruited with the expectation that at least 40 will complete the study. The placebo-controlled, crossover study design will allow for a direct comparison of dose-response within the same participant. The investigators anticipate that the bioactive components of strawberries will reduce LDL-C and blood pressure, and modify the gut microbiome, with greater changes on the high dose. There is preliminary evidence that polyphenol-rich foods can modify gut microbiota profiles, but this would be th
Interventions
- DIETARY_SUPPLEMENT Placebo powder
- DIETARY_SUPPLEMENT Strawberry powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2021-03-23 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03522974
The ClinicalTrials.gov registry entry for NCT03522974 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo powder is the first listed.
NCT03522974 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03522974 about?
NCT03522974 is a clinical study titled "Effects of Freeze Dried Strawberry Powder Supplementation on Cardiovascular Risk Factors and Gut Microbiome". Dietary interventions designed to promote health by increasing the consumption of particular health-promoting foods (e.g., strawberries) generally target blood pressure and LDL-C; however, CVD risk reduction may also be achieved via changes in emerging endpoints such as the gut microbiome. Previous ...
What is the current status of trial NCT03522974?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2019-11-01. Estimated completion is 2021-03-23.
What interventions are being tested in trial NCT03522974?
The interventions under investigation include: Placebo powder (DIETARY_SUPPLEMENT), Strawberry powder (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03522974?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
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