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Paleolithic Diet in the Treatment of Glucose Intolerance

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ClinicalTrials.gov Identifier: NCT00419497
Recruitment Status : Completed
First Posted : January 8, 2007
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Coronary Heart Disease Behavioral: Paleolithic diet vs Mediterranean diet Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Paleolithic Diet in the Treatment of Glucose Intolerance
Study Start Date : January 2003
Primary Completion Date : June 2007
Study Completion Date : June 2007
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. change in weight and waist circumference [ Time Frame: 12 weeks ]
  2. area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test [ Time Frame: 12 weeks ]
  3. area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. fasting plasma glucose [ Time Frame: 12 weeks ]
  2. 30-min plasma glucose [ Time Frame: 12 weeks ]
  3. 120-min plasma glucose [ Time Frame: 12 weeks ]
  4. fasting plasma insulin [ Time Frame: 12 weeks ]
  5. 30-min plasma insulin [ Time Frame: 12 weeks ]
  6. 120-min plasma insulin [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Staffan Lindeberg, Ass prof, Lund University Hospital
ClinicalTrials.gov Identifier: NCT00419497     History of Changes
Other Study ID Numbers: LU 665-02
First Posted: January 8, 2007    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Staffan Lindeberg, 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