Paleolithic Diet in the Treatment of Glucose Intolerance

Last updated: September 18, 2016
Sponsor: Lund University Hospital
Overall Status: Completed

Phase

2/3

Condition

Myocardial Ischemia

Coronary Artery Disease

Heart Disease

Treatment

N/A

Clinical Study ID

NCT00419497
LU 665-02
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Hyperglycemia

  • Coronary Heart Disease

  • Increased waist circumference

Exclusion

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

Study Design

Total Participants: 29
Study Start date:
January 01, 2003
Estimated Completion Date:
June 30, 2007

Study Description

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.

Connect with a study center

  • Lund University Hospital

    Lund, 22185
    Sweden

    Site Not Available

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