Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT00548782
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-24
• Primary Completion: 2013-06
• Study Completion: 2016-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Type 2 diabetic patients
• Age >= 18 yrs
• BMI < 40 kg/m2
• Normal cardiac, renal and hepatic function

Exclusion Criteria

• Subjects on thiazolidinediones ( Avandia, Actos) or other medications that interfere with the testing procedures
• Subjects unwilling or unable to follow the diet specified
• Pregnant women
• Subjects who are unable to understand the consent form
• Hematocrit less than 30
• Patients with defibrillators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
decreased insulin secretion	2 months

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States