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NCT00548782 · ClinicalTrials.gov registry record · NA
Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT00548782 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 22 participants.
The verdict
NCT00548782, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study Summary
This study proposes to evaluate the physiological effects of eating Paleolithic type diet ("hunter-gatherer's diet") on Type 2 diabetic patients. The diet essentially consists of fruits, vegetables, nuts, lean meats, excludes dairy products and grains.Subjects will be randomized into taking either ADA (American Diabetic Association) recommended diet or Paleolithic diet for 21 days. The research kitchen will provide all food items and total calories in both groups will be adjusted to maintain baseline weight. Blood and urine test will be done in the first 3 days, last 3 days and 1 month after the study period to study and compare the effects of the two diets on subjects glucose control, lipid profile and other parameters of cardiovascular physiology. We hypothesize that a palaeolithic diet in subjects with Type 2 diabetes mellitis, will result in improvement in above parameters and lead to improvement in glucose control with less need for diabetes medicines (either lower doses or fewer medications) to a greater extent than in subjects fed with ADA diet, without any change in weight. We also expect a beneficial effect on blood vessel function, lipid profiles and blood pressure.
Interventions
- OTHER Paleolithic diet
- OTHER ADA ( American Diabetes Association) recommended diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2007-09 |
| Est. Completion | 2016-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00548782
The ClinicalTrials.gov registry entry for NCT00548782 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Paleolithic diet is the first listed.
NCT00548782 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00548782 about?
NCT00548782 is a clinical study titled "Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome". This study proposes to evaluate the physiological effects of eating Paleolithic type diet ("hunter-gatherer's diet") on Type 2 diabetic patients. The diet essentially consists of fruits, vegetables, nuts, lean meats, excludes dairy products and grains.Subjects will be randomized into taking either A...
What is the current status of trial NCT00548782?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2007-09. Estimated completion is 2016-09.
What interventions are being tested in trial NCT00548782?
The interventions under investigation include: Paleolithic diet (OTHER), ADA ( American Diabetes Association) recommended diet (OTHER).
Who is sponsoring clinical trial NCT00548782?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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