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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: Completed NA study, sponsored by Oklahoma State University.
NCT01883401 is a NA study that has completed, run by Oklahoma State University. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in lipids and lipoproteins at screen and 12 weeks of the study
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 |
What the finished NCT01883401 record still lists
NCT01883401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Dietary fiber is the first listed.
NCT01883401 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01883401's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 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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