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Paleolithic Diet in the Treatment of Diabetes Type 2 in Primary Health Care

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00435240
Enrollment
13
Registered
2007-02-14
Start date
2005-01-31
Completion date
2007-09-30
Last updated
2008-05-15

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

Conditions

Diabetes Mellitus, Type 2

Brief summary

There is uncertainty about the optimal diet in the prevention and treatment of diabetes type 2. Earlier studies have generally focused on intakes of fat, protein, carbohydrate, fiber, fruit and vegetables. This study is based on another approach which compares foods that were available during human evolution with more recently introduced ones. The basic tenet from evolutionary biology is that if human physiology is less adapted to a relatively recently introduced diet based on agriculture, this could cause disturbances to human physiology and ultimately lead to diseases. Epidemiological studies indicates that diabetes mellitus type 2 is absent or near absent in populations eating a Palaeolithic (Old Stone Age) diet which is free from food items produced in agriculture or the food industry. Our study hypothesis is that a Palaeolithic diet is better than the standard diabetes diet recommended today in treating diabetes type 2. Fifteen patients with diabetes type 2 have been randomized to 1. a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts 2. a standard diabetes diet as recommended by national health authorities. The patients eat the diet they have been randomized to for three months and then switches to the other diet for another three months. The study is conducted in Primary Health Care stations.

Interventions

Sponsors

Lund University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults with capacity to perform study * Diabetes Mellitus Type 2 * C-peptide \> 0 * HbA1C \>5.5 * Unchanged diabetes treatment during last 3 months * Weight and HbA1C varied less than 5% during last 3 months * No acute heart disease during last 6 months * Unchanged treatment with betablocker last 6 months * Unchanged treatment with thyroid hormone substitution last 6 months

Exclusion criteria

* Treatment with insulin * Chronic treatment with steroids (not inhaled) * Treatment with Waran (anticoagulant cumarin type) * Creatinin \> 130 micromol/L * Elevated liver enzymes (ALAT,ASAT,ALP or GT \> 4 X upper reference value) * Acute heart disease * Changed treatment with betablocker or thyroid hormone substitution

Design outcomes

Primary

MeasureTime frame
area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months
area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months
HbA1C at baseline, 3 months and 6 months
weight at baseline, 3 months and 6 months
waist circumference at baseline, 3 months and 6 months

Secondary

MeasureTime frame
Blood lipids at baseline, 3 months and 6 months
satiation measured on visual semi-analogous scale at food intake during 4 days av 6 weeks and 12 weeks
C-reactive protein at baseline, 3 months and 6 months
leptin at baseline, 3 months and 6 months
fasting plasma glucose at baseline, 3 months and 6 months
fasting plasma insulin at baseline, 3 months and 6 months
Systolic and diastolic blod pressure at baseline, 3 months and 6 months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026