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Paleolithic Diet in the Treatment of Glucose Intolerance

Paleolithic Diet in the Treatment of Glucose Intolerance

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00419497
Enrollment
29
Registered
2007-01-08
Start date
2003-01-31
Completion date
2007-06-30
Last updated
2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Hyperglycemia

Keywords

Paleolithic diet, Mediterranean-style diet, Glucose tolerance, Diabetes type 2, Weight loss, Waist

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.

Interventions

BEHAVIORALPaleolithic diet vs Mediterranean diet

Prudent diets with or without grains and dairy

Sponsors

Lund University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
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 * 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

Design outcomes

Primary

MeasureTime frame
change in weight and waist circumference12 weeks
area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test12 weeks
area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test12 weeks

Secondary

MeasureTime frame
fasting plasma insulin12 weeks
fasting plasma glucose12 weeks
120-min plasma insulin12 weeks
30-min plasma insulin12 weeks
30-min plasma glucose12 weeks
120-min plasma glucose12 weeks

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026