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Paleolithic Diets and T2D
This study is currently recruiting participants.
Verified by University of California, San Francisco, September 2007
Sponsored by: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00548782
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Other: Paleolithic diet
Other: ADA ( American Diabetes Association) recommended diet

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: Paleolithic Diets and Metabolic Control in Type 2 Diabetes Mellitus

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • decreased insulin secretion [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2007
Arms Assigned Interventions
A: Active Comparator
Subjects will be placed on Paleolithic diet
Other: Paleolithic diet
B: Active Comparator
Subjects will be placed on ADA ( American Diabetes Association) recommended diet
Other: ADA ( American Diabetes Association) recommended diet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548782

Contacts
Contact: Pooja Sherchan, MD 4153539075 pooja_sherchan1@yahoo.com
Contact: Lynda Frassetto, MD 4154766143 frassett@gcrc.ucsf.edu

Locations
United States, California
University of California San Francisco Recruiting
San Franciscco, California, United States, 94143
Contact: Umesh Masharani, MD     415-353-2664     Umesh.Masharani@ucsf.edu    
Contact: Lynda Frassetto, MD     415 476-6143     frassett@gcrc.ucsf.edu    
Principal Investigator: Umesh Masharani, MD            
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Franca Angeli, MD University of California, San Francisco
Principal Investigator: Umesh Masharani, MRCP University of California, San Francisco
Principal Investigator: Lynda Frassetto, MD University of California, San Francisco
Study Director: Pooja Sherchan, MD University of California, San Francisco
  More Information

Study ID Numbers: H84763129001
Study First Received: October 22, 2007
Last Updated: June 2, 2008
ClinicalTrials.gov Identifier: NCT00548782  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009