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Paleolithic Diet in the Treatment of Glucose Intolerance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Staffan Lindeberg, Lund University Hospital
ClinicalTrials.gov Identifier:
NCT00419497
First received: January 4, 2007
Last updated: September 18, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Hyperglycemia
Coronary Heart Disease
Behavioral: Paleolithic diet vs Mediterranean diet
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Paleolithic Diet in the Treatment of Glucose Intolerance

Resource links provided by NLM:


Further study details as provided by Lund University Hospital:

Primary Outcome Measures:
  • change in weight and waist circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 30-min plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 120-min plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • fasting plasma insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 30-min plasma insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 120-min plasma insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: January 2003
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paleolithic diet vs Mediterranean diet
Prudent diets with or without grains and dairy
Behavioral: Paleolithic diet vs Mediterranean diet
Prudent diets with or without grains and dairy

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419497

Locations
Sweden
Lund University Hospital
Lund, Sweden, 22185
Sponsors and Collaborators
Lund University Hospital
Investigators
Principal Investigator: Staffan Lindeberg, MD PhD Department of Clinical Sciences, IKVL 1, Lund University, Lund Sweden
  More Information

Publications:
Responsible Party: Staffan Lindeberg, Ass prof, Lund University Hospital
ClinicalTrials.gov Identifier: NCT00419497     History of Changes
Other Study ID Numbers: LU 665-02 
Study First Received: January 4, 2007
Last Updated: September 18, 2016
Health Authority: Sweden: The National Board of Health and Welfare
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Lund University Hospital:
Paleolithic diet
Mediterranean-style diet
Glucose tolerance
Diabetes type 2
Weight loss
Waist

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Hyperglycemia
Glucose Intolerance
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 23, 2016