Ignite Creation Date:
2024-05-05 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00548782
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2007-10-22
Brief Title:
Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Paleolithic Diets and Metabolic Control in Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study proposes to evaluate the physiological effects of eating Paleolithic type diet hunter-gatherers diet on Type 2 diabetic patients The diet essentially consists of fruits vegetables nuts lean meats excludes dairy products and grainsSubjects 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
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-gatherers diet on Type 2 diabetic patients The diet essentially consists of fruits vegetables nuts lean meats excludes dairy products and grainsSubjects 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None