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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paleolithic diet vs Mediterranean diet | Active Comparator | Prudent diets with or without grains and dairy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paleolithic diet vs Mediterranean diet | Behavioral | Prudent diets with or without grains and dairy |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in weight and waist circumference | 12 weeks | |
| area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test | 12 weeks | |
| area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| fasting plasma glucose | 12 weeks | |
| 30-min plasma glucose | 12 weeks | |
| 120-min plasma glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Staffan Lindeberg, MD PhD | Department of Clinical Sciences, IKVL 1, Lund University, Lund Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lund University Hospital | Lund | 22185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17583796 | Result | Lindeberg S, Jonsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjostrom K, Ahren B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-1807. doi: 10.1007/s00125-007-0716-y. Epub 2007 Jun 22. | |
| 21118562 | Derived |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D003327 | Coronary Disease |
| D003924 | Diabetes Mellitus, Type 2 |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017202 | Myocardial Ischemia |
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| 12 weeks |
| fasting plasma insulin | 12 weeks |
| 30-min plasma insulin | 12 weeks |
| 120-min plasma insulin | 12 weeks |
| Jonsson T, Granfeldt Y, Erlanson-Albertsson C, Ahren B, Lindeberg S. A paleolithic diet is more satiating per calorie than a mediterranean-like diet in individuals with ischemic heart disease. Nutr Metab (Lond). 2010 Nov 30;7:85. doi: 10.1186/1743-7075-7-85. |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |