Paleolithic Diet in the Treatment of Glucose Intolerance

Coronary Heart Disease Clinical Trial

Official title:

Paleolithic Diet in the Treatment of Glucose Intolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419497
• Other study ID #: LU 665-02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 4, 2007
• Last updated: September 18, 2016
• Start date: January 2003
• Est. completion date: June 2007

Study information

• Verified date: September 2016
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Glucose Intolerance
• Heart Diseases
• Hyperglycemia
• Myocardial Ischemia

Intervention

Behavioral:
• Paleolithic diet vs Mediterranean diet
Prudent diets with or without grains and dairy

Locations

Country	Name	City	State
Sweden	Lund University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Lindeberg S, Jönsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjöström K, Ahrén B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-807. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in weight and waist circumference		12 weeks	No
Primary	area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test		12 weeks	No
Primary	area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test		12 weeks	No
Secondary	fasting plasma glucose		12 weeks	No
Secondary	30-min plasma glucose		12 weeks	No
Secondary	120-min plasma glucose		12 weeks	No
Secondary	fasting plasma insulin		12 weeks	No
Secondary	30-min plasma insulin		12 weeks	No
Secondary	120-min plasma insulin		12 weeks	No