Viewing Study NCT00435240



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Last Modification Date: 2024-10-26 @ 9:30 AM
Study NCT ID: NCT00435240
Status: COMPLETED
Last Update Posted: 2008-05-15
First Post: 2007-02-13

Brief Title: Paleolithic Diet in the Treatment of Diabetes Type 2 in Primary Health Care
Sponsor: Lund University Hospital
Organization: Lund University Hospital

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2008-05
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: There is uncertainty about the optimal diet in the prevention and treatment of diabetes type 2 Earlier studies have generally focused on intakes of fat protein carbohydrate fiber fruit and vegetables This study is based on another approach which compares foods that were available during human evolution with more recently introduced ones The basic tenet from evolutionary biology is that if human physiology is less adapted to a relatively recently introduced diet based on agriculture this could cause disturbances to human physiology and ultimately lead to diseases Epidemiological studies indicates that diabetes mellitus type 2 is absent or near absent in populations eating a Palaeolithic Old Stone Age diet which is free from food items produced in agriculture or the food industry Our study hypothesis is that a Palaeolithic diet is better than the standard diabetes diet recommended today in treating diabetes type 2

Fifteen patients with diabetes type 2 have been randomized to

1 a Palaeolithic diet based on lean meat fish fruit vegetables root vegetables eggs and nuts
2 a standard diabetes diet as recommended by national health authorities

The patients eat the diet they have been randomized to for three months and then switches to the other diet for another three months The study is conducted in Primary Health Care stations
Detailed Description: None

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