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NCT02224365 · ClinicalTrials.gov registry record · Phase 2
The Effects of Apple Consumption on Cardiovascular Health in Prediabetics and Type 2 Diabetics
A Phase 2 study, sponsored by Florida State University.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT02224365: Completed Phase 2 study, sponsored by Florida State University.
NCT02224365 is a Phase 2 study that has completed, run by Florida State University. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02224365, a Phase 2 study, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
The hypothesis of this study is that the daily consumption of 75 g dried apple powder for twelve weeks will improve arterial stiffness and blood pressure by improving endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering biochemical markers associated with cardiovascular risk and glycemic control compared to a macronutrient-matched control powder. 50 men and women between the ages of 45 and 65 with prediabetes or type 2 diabetes who are overweight or obese will be included in the study. After a two-week run-in phase, eligible men and women will be randomly assigned to one of two treatment groups: 1) 75 g dried apple powder; or 2) 75 g placebo powder daily for twelve weeks. After an initial telephone screening, all participants will be requested to report to the study site for their first visit. On the first visit (screening), participants will be provided with verbal and written explanation of the project. They will then be asked to sign an informed consent form, followed by measuring fasting glucose levels and a medical history questionnaire to confirm prediabetes or type 2 diabetes. Baseline assessments will be performed for medical history, medication use, dietary intake, and physical activity. Qualified participants will be scheduled for their second visit two weeks later (actual baseline data collection) and randomly assigned to their treatment group. On the second (baseline) visit between the hours of 6:00-11:00 A.M., blood pressure and vascular function will be measured followed by blood draw and urine collection. Anthropometrics will be measured. Participants will be provided with their assigned treatment and will receive standard instructions on how to fill out daily diaries for their treatment, and for food and physical activity records. Blood pressure, vascular function, blood draw, urine collection, and anthropometric, body composition, diet, and physical activity assessments will be repeated at 6- (third visit), and
Primary Outcome
By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Apple
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT02224365 record still lists
NCT02224365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02224365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02224365 about?
NCT02224365 is a clinical study titled "The Effects of Apple Consumption on Cardiovascular Health in Prediabetics and Type 2 Diabetics". The hypothesis of this study is that the daily consumption of 75 g dried apple powder for twelve weeks will improve arterial stiffness and blood pressure by improving endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering biochemical markers associated with cardio...
What is the current status of trial NCT02224365?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2014-08. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02224365?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Apple (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02224365?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02224365's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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