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Completed

NCT Number: NCT00419497

Paleolithic Diet in the Treatment of Glucose Intolerance

The purpose of this study is to determine whether a paleolithic diet improves glucose tolerance and insulin sensitivity in people with coronary heart disease and impaired glucose tolerance.

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Key information

About this study

There is uncertainty about the optimal diet in the prevention and treatment of glucose intolerance and diabetes type 2, disorders which are very common in patients with coronary heart disease (CHD). Earlier studies have generally focused on intakes of fat, carbohydrate, fiber, fruit and vegetables. Another approach compares foods that were available during human evolution with more recently introduced ones. Twenty-nine CHD patients with glucose intolerance or diabetes have been randomized to 1) a Paleolithic ("Old Stone Age") diet (n=14) based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts, or 2) a Consensus (Mediterranean-like) diet (n=15) based on whole grains, low-fat dairy products, vegetables, fruit, fish, and oils and margarines generally assumed to be healthy. Primary outcome variables are changes during 12 weeks in weight, waist circumference, and area under the curve for glucose (AUC Glucose0-120) and insulin (AUC Insulin0-120) at the oral glucose tolerance test.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hyperglycemia
  • Coronary Heart Disease
  • Increased waist circumference

Exclusion criteria

  • Body mass index <20 kg/m2
  • Serum creatinine >130 µmol/L
  • Poor general condition
  • Dementia
  • Unwillingness/inability to prepare food at home (by study participant or partner)
  • Participation in another medical trial
  • Chronic inflammatory bowel disease
  • Drug treatment with hypoglycemic agents
  • Drug treatment with warfarin
  • Drug treatment with oral steroid

Treatment and study plan

Paleolithic diet vs Mediterranean diet

Behavioral

Prudent diets with or without grains and dairy

Primary outcomes

  1. change in weight and waist circumference

    Time frame: 12 weeks

  2. area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test

    Time frame: 12 weeks

  3. area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test

    Time frame: 12 weeks

Secondary outcomes

  1. fasting plasma glucose

    Time frame: 12 weeks

  2. 30-min plasma glucose

    Time frame: 12 weeks

  3. 120-min plasma glucose

    Time frame: 12 weeks

  4. fasting plasma insulin

    Time frame: 12 weeks

  5. 30-min plasma insulin

    Time frame: 12 weeks

  6. 120-min plasma insulin

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Jan 8, 2007
Registry last updated
Sep 20, 2016

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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