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Clinical Trials/NCT00419497
NCT00419497CompletedPhase 2

Paleolithic Diet in the Treatment of Glucose Intolerance

Lund University Hospital2 sites in 1 country29 target enrollmentStarted: January 2003Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Staffan Lindeberg

Ass prof

Lund University Hospital

Study Sites (2)

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