Clinical Trials Directory

Trials / Completed

CompletedNCT00435240

Paleolithic Diet in the Treatment of Diabetes Type 2 in Primary Health Care

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Lund University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPaleolithic diet

Timeline

Start date
2005-01-01
Primary completion
2007-09-01
Completion
2007-09-01
First posted
2007-02-14
Last updated
2008-05-15

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT00435240. Inclusion in this directory is not an endorsement.