Paleolithic Diet in the Treatment of Glucose Intolerance
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Lund University Hospital
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- change in weight and waist circumference
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- fasting plasma insulin(12 weeks)
- 120-min plasma glucose(12 weeks)
- fasting plasma glucose(12 weeks)
- 30-min plasma glucose(12 weeks)
- 30-min plasma insulin(12 weeks)
- 120-min plasma insulin(12 weeks)
Investigators
Staffan Lindeberg
Ass prof
Lund University Hospital