Paleolithic Diet in the Treatment of Glucose Intolerance

Lund University Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Coronary Heart Disease; Hyperglycemia

Treatments: Behavioral: Paleolithic diet vs Mediterranean diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00419497

LU 665-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Paleolithic diet vs Mediterranean diet

Active Comparator group

Description:

Prudent diets with or without grains and dairy

Treatment:

Behavioral: Paleolithic diet vs Mediterranean diet