Paleolithic Diet in the Treatment of Glucose Intolerance

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Paleolithic Diet in the Treatment of Glucose Intolerance

Conditions
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Hyperglycemia, Coronary Heart Disease

Intervention / Treatment
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* Behavioral: Paleolithic diet vs Mediterranean diet


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paleolithic diet vs Mediterranean diet<br>Prudent diets with or without grains and dairy | Behavioral: Paleolithic diet vs Mediterranean diet<br>* Prudent diets with or without grains and dairy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting plasma glucose |  | 12 weeks | 
| 30-min plasma glucose |  | 12 weeks | 
| 120-min plasma glucose |  | 12 weeks | 
| fasting plasma insulin |  | 12 weeks | 
| 30-min plasma insulin |  | 12 weeks | 
| 120-min plasma insulin |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paleolithic diet, Mediterranean-style diet, Glucose tolerance, Diabetes type 2, Weight loss, Waist