Paleolithic Diet in the Treatment of Glucose Intolerance

This study has been completed.
Sponsor:
Information provided by:
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT00419497
First received: January 4, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted

January 4, 2007
January 4, 2007
January 2003
Not Provided
  • weight
  • waist circumference
  • area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test
  • area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test
Same as current
No Changes Posted
  • fasting plasma glucose
  • 30-min plasma glucose
  • 120-min plasma glucose
  • fasting plasma insulin
  • 30-min plasma insulin
  • 120-min plasma insulin
Same as current
Not Provided
Not Provided
 
Paleolithic Diet in the Treatment of Glucose Intolerance
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hyperglycemia
  • Coronary Heart Disease
Behavioral: Paleolithic diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2006
Not Provided

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00419497
LU 665-02
Not Provided
Not Provided
Lund University Hospital
Not Provided
Principal Investigator: Staffan Lindeberg, MD PhD Department of Clinical Sciences, IKVL 1, Lund University, Lund Sweden
Lund University Hospital
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP