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

Lund University Hospital

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Paleolithic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00435240

H4 726/2004

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with capacity to perform study
• Diabetes Mellitus Type 2
• C-peptide > 0
• HbA1C >5.5
• Unchanged diabetes treatment during last 3 months
• Weight and HbA1C varied less than 5% during last 3 months
• No acute heart disease during last 6 months
• Unchanged treatment with betablocker last 6 months
• Unchanged treatment with thyroid hormone substitution last 6 months

Exclusion criteria

• Treatment with insulin
• Chronic treatment with steroids (not inhaled)
• Treatment with Waran (anticoagulant cumarin type)
• Creatinin > 130 micromol/L
• Elevated liver enzymes (ALAT,ASAT,ALP or GT > 4 X upper reference value)
• Acute heart disease
• Changed treatment with betablocker or thyroid hormone substitution

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)