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NCT02228837 · ClinicalTrials.gov registry record · Phase 2
The Health-Promoting Role of Pears in Men and Women With Metabolic Syndrome
A Phase 2 study of Metabolic Syndrome, sponsored by Florida State University.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT02228837 is a Phase 2 study of Metabolic Syndrome that has completed, run by Florida State University. The registered enrollment target is 50 participants, below the 1,204-participant average among 102 other Metabolic Syndrome trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02228837, a Phase 2 study of Metabolic Syndrome, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The hypothesis of this study is that the daily consumption of 2 medium-sized pears for twelve weeks will improve blood pressure, lipid profiles, glycemic control and insulin resistance, inflammatory and oxidative status in men and women with metabolic syndrome. 50 men and women between the ages of 45 and 65 who have three of the five features of metabolic syndrome as defined by the Adult Treatment Panel III 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) 2 medium-sized pears; or 2) 50 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 waist circumference, resting brachial blood pressure, fasting serum triglycerides, high density lipoprotein cholesterol, and glucose levels to confirm metabolic syndrome. 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 6-11 A.M., blood pressure will be measured followed by blood draw and urine collection. Anthropometrics and body composition will be measured. Questionnaires regarding diet, physical activity, and gastrointestinal health will be performed. Participants will be provided with their assigned treatment and will receive standard instructions on how to fill out daily diaries for their treatment. All assessments will be repeated at 6- (third visit), and 12-week (final visit) intervals. All assessments and information will be collected after an overnight
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Pear
Study Locations (1)
Florida
- Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University - Tallahassee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02228837
The ClinicalTrials.gov registry entry for NCT02228837 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,204-participant average among 102 other Metabolic Syndrome trials with a reported enrollment target (96% lower). The listed sponsor is Florida State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metabolic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02228837 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT02228837 about?
NCT02228837 is a clinical study titled "The Health-Promoting Role of Pears in Men and Women With Metabolic Syndrome". The hypothesis of this study is that the daily consumption of 2 medium-sized pears for twelve weeks will improve blood pressure, lipid profiles, glycemic control and insulin resistance, inflammatory and oxidative status in men and women with metabolic syndrome. 50 men and women between the ages of 4...
What is the current status of trial NCT02228837?
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 2016-05.
What conditions does trial NCT02228837 study?
This clinical trial studies the following conditions: Metabolic Syndrome.
What interventions are being tested in trial NCT02228837?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Pear (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02228837?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02228837 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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