Clinical trial NCT00419497: Paleolithic Diet in the Treatment of Glucose Intolerance
Official title: Paleolithic Diet in the Treatment of Glucose Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hyperglycemia
Coronary Heart Disease
Keywords: Paleolithic diet
Mediterranean-style diet
Glucose tolerance
Diabetes type 2
Weight loss
Waist
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2007-01-08
Enrollment: 29
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in weight and waist circumference
timeFrame: 12 weeks
measure: area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test
timeFrame: 12 weeks
measure: area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test
timeFrame: 12 weeks
Secondary outcomes:
measure: fasting plasma glucose
timeFrame: 12 weeks
measure: 30-min plasma glucose
timeFrame: 12 weeks
measure: 120-min plasma glucose
timeFrame: 12 weeks
measure: fasting plasma insulin
timeFrame: 12 weeks
measure: 30-min plasma insulin
timeFrame: 12 weeks
measure: 120-min plasma insulin
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University Hospital
Study officials:
affiliation: Department of Clinical Sciences, IKVL 1, Lund University, Lund Sweden
name: Staffan Lindeberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.