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Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome

NCT00548782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-02-28

No results posted yet for this 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.

Conditions

Interventions

OTHER

Paleolithic diet

diet

OTHER

ADA ( American Diabetes Association) recommended diet

diet

Sponsors & Collaborators

Principal Investigators

  • Franca Angeli, MD · University of California, San Francisco

  • Umesh Masharani, MRCP · University of California, San Francisco

  • Lynda Frassetto, MD · University of California, San Francisco

  • Shelley MCCoy · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2013-06-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00548782 on ClinicalTrials.gov