Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome
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|ClinicalTrials.gov Identifier: NCT00548782|
Recruitment Status : Completed
First Posted : October 24, 2007
Last Update Posted : June 21, 2013
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 or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Other: Paleolithic diet Other: ADA ( American Diabetes Association) recommended diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Paleolithic Diets and Metabolic Control in Type 2 Diabetes Mellitus|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||June 2013|
Active Comparator: A
Subjects will be placed on Paleolithic diet and markers of insulin resistance, lipid profiles and vascular reactivity will be measured.
Other: Paleolithic 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.
Other: ADA ( American Diabetes Association) recommended diet
- decreased insulin secretion [ Time Frame: 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548782
|United States, California|
|University of California San Francisco|
|San Franciscco, California, United States, 94143|
|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:||Shelley MCCoy||University of California, San Francisco|