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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00435240
• Lead Sponsor: Lund University Hospital

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

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2007-02-13
• Study First Submitted QC: 2007-02-13
• Study First Posted: 2007-02-14
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-13
• Last Update Posted: 2008-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months
area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months
waist circumference at baseline, 3 months and 6 months
HbA1C at baseline, 3 months and 6 months
weight at baseline, 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
fasting plasma glucose at baseline, 3 months and 6 months
Systolic and diastolic blod pressure at baseline, 3 months and 6 months
Blood lipids at baseline, 3 months and 6 months
satiation measured on visual semi-analogous scale at food intake during 4 days av 6 weeks and 12 weeks
leptin at baseline, 3 months and 6 months
fasting plasma insulin at baseline, 3 months and 6 months
C-reactive protein at baseline, 3 months and 6 months

Trial Locations

Locations (1)

Lund University Hospital; 🇸🇪 Lund, Skåne, Sweden