Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome

Paleolithic Diets and Metabolic Control in Type 2 Diabetes Mellitus

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Paleolithic diet; Other: ADA ( American Diabetes Association) recommended diet

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Paleolithic diet; diet
Active Comparator: 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.	Other: ADA ( American Diabetes Association) recommended diet; diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
decreased insulin secretion	2 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: lynda frassetto, md, University of California, San Francisco; Principal Investigator: Franca Angeli, MD, University of California, San Francisco; Principal Investigator: Umesh Masharani, MRCP, University of California, San Francisco; Study Director: Shelley MCCoy, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 22, 2007
• First Submitted That Met QC Criteria: October 22, 2007
• First Posted (Estimate): October 24, 2007

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: H84763129001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No