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NCT Number: NCT00435240

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lund University Hospital

Lund, Skåne County, 22185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paleolithic diet

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Feb 14, 2007
Registry last updated
May 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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