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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: Completed NA study, sponsored by University of California, San Francisco.

NCT00548782 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 22 participants
Start Date 2007-09
Est. Completion 2016-09
Phase NA

What the finished NCT00548782 record still lists

NCT00548782 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Paleolithic diet is the first listed.

NCT00548782 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00548782's enrollment target sits among peer trials

22 1756th of 2000 higher than 239 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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Source: ClinicalTrials.gov NCT00548782, the US trial registry maintained by the National Library of Medicine. NCT00548782 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.