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

Diabetes Mellitus, Type 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435240
• Other study ID #: H4 726/2004
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2007
• Last updated: May 13, 2008
• Start date: January 2005
• Est. completion date: September 2007

Study information

• Verified date: May 2008
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Paleolithic diet

Locations

Country	Name	City	State
Sweden	Lund University Hospital	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Cordain L, Eaton SB, Sebastian A, Mann N, Lindeberg S, Watkins BA, O'Keefe JH, Brand-Miller J. Origins and evolution of the Western diet: health implications for the 21st century. Am J Clin Nutr. 2005 Feb;81(2):341-54. Review. — View Citation

Jönsson T, Ahrén B, Pacini G, Sundler F, Wierup N, Steen S, Sjöberg T, Ugander M, Frostegård J, Göransson L, Lindeberg S. A Paleolithic diet confers higher insulin sensitivity, lower C-reactive protein and lower blood pressure than a cereal-based diet in domestic pigs. Nutr Metab (Lond). 2006 Nov 2;3:39. — View Citation

Jönsson T, Olsson S, Ahrén B, Bøg-Hansen TC, Dole A, Lindeberg S. Agrarian diet and diseases of affluence--do evolutionary novel dietary lectins cause leptin resistance? BMC Endocr Disord. 2005 Dec 10;5:10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months
Primary	area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months
Primary	HbA1C at baseline, 3 months and 6 months
Primary	weight at baseline, 3 months and 6 months
Primary	waist circumference at baseline, 3 months and 6 months
Secondary	satiation measured on visual semi-analogous scale at food intake during 4 days av 6 weeks and 12 weeks
Secondary	leptin at baseline, 3 months and 6 months
Secondary	fasting plasma glucose at baseline, 3 months and 6 months
Secondary	fasting plasma insulin at baseline, 3 months and 6 months
Secondary	Systolic and diastolic blod pressure at baseline, 3 months and 6 months
Secondary	Blood lipids at baseline, 3 months and 6 months
Secondary	C-reactive protein at baseline, 3 months and 6 months