Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome

NCT ID: NCT00548782

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2016-09-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A

Subjects will be placed on Paleolithic diet and markers of insulin resistance, lipid profiles and vascular reactivity will be measured. a paleolithic diet excludes dairy, grains, legumes and processed foods.

Group Type: ACTIVE_COMPARATOR

Paleolithic diet

Intervention Type: OTHER

diet

B

Subjects will be placed on ADA ( American Diabetes Association) recommended diet and markers of insulin resistance, lipid profiles and vascular reactivity will be measured. An ADA diet is lower fat and more whole grains.

Group Type: ACTIVE_COMPARATOR

ADA ( American Diabetes Association) recommended diet

Intervention Type: OTHER

diet

Interventions

Paleolithic diet

diet

Intervention Type: OTHER

ADA ( American Diabetes Association) recommended diet

diet

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franca Angeli, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Umesh Masharani, MRCP

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Lynda Frassetto, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Shelley MCCoy

Role: STUDY_DIRECTOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

H84763129001

Identifier Type: -

Identifier Source: org_study_id