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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00548782 |
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 |
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Type 2 Diabetes Mellitus |
Other: Paleolithic diet Other: ADA ( American Diabetes Association) recommended diet |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | September 2007 |
Arms | Assigned Interventions |
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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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pooja Sherchan, MD | 4153539075 | pooja_sherchan1@yahoo.com |
Contact: Lynda Frassetto, MD | 4154766143 | frassett@gcrc.ucsf.edu |
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 |
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 |
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 |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |