Clinical trial NCT00548782: Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome
Official title: Paleolithic Diets and Metabolic Control in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2007-10-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: decreased insulin secretion
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Franca Angeli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Umesh Masharani, MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Lynda Frassetto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Shelley MCCoy
role: STUDY_DIRECTOR
References: