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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00435240
Recruitment Status : Completed
First Posted : February 14, 2007
Last Update Posted : May 15, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Paleolithic diet Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months
  2. area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months
  3. HbA1C at baseline, 3 months and 6 months
  4. weight at baseline, 3 months and 6 months
  5. waist circumference at baseline, 3 months and 6 months

Secondary Outcome Measures :
  1. satiation measured on visual semi-analogous scale at food intake during 4 days av 6 weeks and 12 weeks
  2. leptin at baseline, 3 months and 6 months
  3. fasting plasma glucose at baseline, 3 months and 6 months
  4. fasting plasma insulin at baseline, 3 months and 6 months
  5. Systolic and diastolic blod pressure at baseline, 3 months and 6 months
  6. Blood lipids at baseline, 3 months and 6 months
  7. C-reactive protein at baseline, 3 months and 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435240

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Lund University Hospital
Lund, Skåne, Sweden, 22185
Sponsors and Collaborators
Lund University Hospital
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Principal Investigator: Tommy Jönsson, MD Department of Clinical Sciences, Lund University, Lund Sweden
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Tommy Jönsson, Department of Clinical Sciences, Medical Faculty, Lund University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT00435240    
Other Study ID Numbers: H4 726/2004
First Posted: February 14, 2007    Key Record Dates
Last Update Posted: May 15, 2008
Last Verified: May 2008
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases