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NCT01883401 · ClinicalTrials.gov registry record · NA
Chronic Effects of Freeze-Dried Strawberry Beverage on Cardiovascular Risk Factors
A NA study, sponsored by Oklahoma State University.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT01883401 is a NA study that has completed, run by Oklahoma State University. The registered enrollment target is 60 participants.
The verdict
NCT01883401, a NA study, has completed, sponsored by Oklahoma State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
Berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia while no such studies with whole strawberries have been reported in the US population. The investigators propose to examine the effects of low and high doses of freeze-dried strawberries on serum glucose, insulin, and lipid profile, biomarkers of oxidative stress and inflammation, in a 12-week randomized controlled trial. Subjects with abdominal adiposity and dyslipidemia (n=15/group) will be recruited at OUHSC and OSU, and randomly assigned to the low (25g/day) or high (50g/day) strawberry dose, or matched control (fiber and calories) group. The strawberry group will consume freeze-dried strawberry beverage (2 cups/day) and the controls will consume 2 cups beverage (fiber +calories) daily for 12 weeks. Blood draws, anthropometrics, blood pressure, and dietary data will be collected at screen, 6 and 12 weeks of the study to determine chronic and acute effects of strawberry intervention. Serum or plasma samples will be analyzed for fasting glucose, insulin, lipid profile including total cholesterol, LDL-, and HDL-cholesterol, triglycerides, lipid particle size, and levels of oxidative stress (malondialdehyde, oxidized LDL, myeloperoxidase), inflammation (high sensitivity C-reactive protein, adiponectin, interleukins) and adhesion molecules. Repeated measures ANOVA will be performed using a 5% significance level. We anticipate a dose response effect in decrease in lipids, oxidative stress or inflammation following strawberry intervention versus controls.
Interventions
- DIETARY_SUPPLEMENT Dietary fiber
- DIETARY_SUPPLEMENT Freeze-dried strawberries
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-04 |
| Est. Completion | 2013-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01883401
The ClinicalTrials.gov registry entry for NCT01883401 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oklahoma State University, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dietary fiber is the first listed.
NCT01883401 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01883401 about?
NCT01883401 is a clinical study titled "Chronic Effects of Freeze-Dried Strawberry Beverage on Cardiovascular Risk Factors". Berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia while no such studies with whole strawberries have been reported in the US population. The investigators propose to examine the effects of low and high doses of freeze-dried strawberries on serum glucose, insul...
What is the current status of trial NCT01883401?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2010-04. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01883401?
The interventions under investigation include: Dietary fiber (DIETARY_SUPPLEMENT), Freeze-dried strawberries (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01883401?
This trial is sponsored by Oklahoma State University, which has 26 total clinical trials registered on ClinicalTrials.gov.
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