Paleolithic Diet in the Treatment of Glucose Intolerance

Phase 2

Completed

• Conditions: Coronary Heart Disease; Hyperglycemia
• Interventions: Behavioral: Paleolithic diet vs Mediterranean diet

• Registration Number: NCT00419497
• Lead Sponsor: Lund University Hospital

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 Timeline

• Study Start: 2003-01
• Study First Submitted: 2007-01-04
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-08
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-18
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paleolithic diet vs Mediterranean diet	Paleolithic diet vs Mediterranean diet	Prudent diets with or without grains and dairy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Lund University Hospital; 🇸🇪 Lund, Sweden