CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Paleolithic dietbehavioral
Likely dose
Not stated in record
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Search/NCT00435240
NCT00435240Phase 2Completed

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

Lund University Hospital·interventional·Posted Feb 14, 2007·Updated May 15, 2008

In Brief

A Phase 2 clinical trial evaluating Paleolithic diet for Diabetes Mellitus, Type 2. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 14, 2007
Enrollment StartJan 1, 2005
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 19.4 years ago

Interventions

Paleolithic dietbehavioral