Paleolithic Diet in the Treatment of Glucose Intolerance
Primary Purpose
Hyperglycemia, Coronary Heart Disease
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Paleolithic diet vs Mediterranean diet
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia focused on measuring Paleolithic diet, Mediterranean-style diet, Glucose tolerance, Diabetes type 2, Weight loss, Waist
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
Sites / Locations
- Lund University Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Paleolithic diet vs Mediterranean diet
Arm Description
Prudent diets with or without grains and dairy
Outcomes
Primary Outcome Measures
change in weight and waist circumference
area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test
area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test
Secondary Outcome Measures
fasting plasma glucose
30-min plasma glucose
120-min plasma glucose
fasting plasma insulin
30-min plasma insulin
120-min plasma insulin
Full Information
NCT ID
NCT00419497
First Posted
January 4, 2007
Last Updated
September 18, 2016
Sponsor
Lund University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00419497
Brief Title
Paleolithic Diet in the Treatment of Glucose Intolerance
Official Title
Paleolithic Diet in the Treatment of Glucose Intolerance
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Coronary Heart Disease
Keywords
Paleolithic diet, Mediterranean-style diet, Glucose tolerance, Diabetes type 2, Weight loss, Waist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paleolithic diet vs Mediterranean diet
Arm Type
Active Comparator
Arm Description
Prudent diets with or without grains and dairy
Intervention Type
Behavioral
Intervention Name(s)
Paleolithic diet vs Mediterranean diet
Intervention Description
Prudent diets with or without grains and dairy
Primary Outcome Measure Information:
Title
change in weight and waist circumference
Time Frame
12 weeks
Title
area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test
Time Frame
12 weeks
Title
area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
fasting plasma glucose
Time Frame
12 weeks
Title
30-min plasma glucose
Time Frame
12 weeks
Title
120-min plasma glucose
Time Frame
12 weeks
Title
fasting plasma insulin
Time Frame
12 weeks
Title
30-min plasma insulin
Time Frame
12 weeks
Title
120-min plasma insulin
Time Frame
12 weeks
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Staffan Lindeberg, MD PhD
Organizational Affiliation
Department of Clinical Sciences, IKVL 1, Lund University, Lund Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
22185
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17583796
Citation
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.
Results Reference
result
PubMed Identifier
21118562
Citation
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.
Results Reference
derived
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Paleolithic Diet in the Treatment of Glucose Intolerance
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