Paleolithic Diet in the Treatment of Glucose Intolerance

NCT ID: NCT00419497

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2007-06-30

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.

Conditions

Hyperglycemia; Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paleolithic diet vs Mediterranean diet

Prudent diets with or without grains and dairy

Group Type: ACTIVE_COMPARATOR

Paleolithic diet vs Mediterranean diet

Intervention Type: BEHAVIORAL

Prudent diets with or without grains and dairy

Interventions

Paleolithic diet vs Mediterranean diet

Prudent diets with or without grains and dairy

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Lund University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Staffan Lindeberg

Ass prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Staffan Lindeberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Sciences, IKVL 1, Lund University, Lund Sweden

Locations

Lund University Hospital

Lund, , Sweden

Countries

Sweden

References

Lindeberg S, Jonsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjostrom K, Ahren B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-1807. doi: 10.1007/s00125-007-0716-y. Epub 2007 Jun 22.

Reference Type: RESULT

PMID: 17583796 (View on PubMed)

Jonsson T, Granfeldt Y, Erlanson-Albertsson C, Ahren B, Lindeberg S. A paleolithic diet is more satiating per calorie than a mediterranean-like diet in individuals with ischemic heart disease. Nutr Metab (Lond). 2010 Nov 30;7:85. doi: 10.1186/1743-7075-7-85.

Reference Type: DERIVED

PMID: 21118562 (View on PubMed)

Other Identifiers

LU 665-02

Identifier Type: -

Identifier Source: org_study_id