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NCT03013764 · ClinicalTrials.gov registry record · NA
Diet Composition and Physical Inactivity on Insulin Sensitivity and β-cell Function
A NA study, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT03013764 is a NA study that has completed, run by University of Missouri-Columbia. The registered enrollment target is 15 participants.
The verdict
NCT03013764, a NA study, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
Physical inactivity results in reductions in glucose tolerance and less sensitivity to insulin. If this inactivity lasts long enough it can result in insulin resistance and type 2 diabetes. A high protein diet can reduce elevated glucose levels in individuals with type 2 diabetes. Thus the investigators are interested in establishing if during a period of inactivity if a diet modification can minimize the glucose changes normally observed with inactivity. The objective of this project is to determine if short-term high protein (HP) feeding protects against the changes in glucose levels normally observed with physical inactivity. The investigators will also examine measures of blood vessel function, blood lipid and blood pressure. Twelve subjects will complete two 10 day study periods of reduced physical activity and will be studied before and after each of these study periods. For their testing subjects will have the following measurements: postprandial glucose responses to a mixed meal, 24 h free living blood pressure control during acute physical inactivity, blood lipids, changes in body composition, changes in circadian rhythm using skin temperature (ibutton), measurement of aerobic capacity (VO2 max), blood vessel responsiveness (flow mediated dilation -FMD) and changes in free living glucose levels (continuous glucose monitoring system (CGMS). Subjects will complete two conditions (high protein -HP vs normal protein - NP diets) in a randomized cross-over design. In the inactive phase subjects will reduce there steps to \<5,000 steps/d while consuming either a HP or NP diet. Completion of the study will take 8-10 weeks.
Interventions
- BEHAVIORAL normal protein diet
- BEHAVIORAL high protein intake
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2015-10 |
| Est. Completion | 2017-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03013764
The ClinicalTrials.gov registry entry for NCT03013764 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which normal protein diet is the first listed.
NCT03013764 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03013764 about?
NCT03013764 is a clinical study titled "Diet Composition and Physical Inactivity on Insulin Sensitivity and β-cell Function". Physical inactivity results in reductions in glucose tolerance and less sensitivity to insulin. If this inactivity lasts long enough it can result in insulin resistance and type 2 diabetes. A high protein diet can reduce elevated glucose levels in individuals with type 2 diabetes. Thus the investiga...
What is the current status of trial NCT03013764?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2015-10. Estimated completion is 2017-09-30.
What interventions are being tested in trial NCT03013764?
The interventions under investigation include: normal protein diet (BEHAVIORAL), high protein intake (BEHAVIORAL).
Who is sponsoring clinical trial NCT03013764?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
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