A Phase 2/3 interventional study of Paleolithic diet vs Mediterranean diet in Hyperglycemia and Coronary Heart Disease, sponsored by Lund University Hospital. Completed at 1 site in Sweden. Open to male participants. Per ClinicalTrials.gov, last updated 2016-09-20.
Sponsored by Lund University Hospital · Phase 2/3, Interventional, and Treatment
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 29 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
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Exclusion Criteria:
Prudent diets with or without grains and dairy
Behavioral: Paleolithic diet vs Mediterranean diet
Prudent diets with or without grains and dairy
change in weight and waist circumference
Time frame: 12 weeks
area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test
Time frame: 12 weeks
area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test
Time frame: 12 weeks
fasting plasma glucose
Time frame: 12 weeks
30-min plasma glucose
Time frame: 12 weeks
120-min plasma glucose
Time frame: 12 weeks
fasting plasma insulin
Time frame: 12 weeks
30-min plasma insulin
Time frame: 12 weeks
120-min plasma insulin
Time frame: 12 weeks
Plan to share: No
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Lund University Hospital