Clinical trial NCT00435240: Paleolithic Diet in the Treatment of Diabetes Type 2 in Primary Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2007-02-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months
measure: area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months
measure: HbA1C at baseline, 3 months and 6 months
measure: weight at baseline, 3 months and 6 months
measure: waist circumference at baseline, 3 months and 6 months
Secondary outcomes:
measure: satiation measured on visual semi-analogous scale at food intake during 4 days av 6 weeks and 12 weeks
measure: leptin at baseline, 3 months and 6 months
measure: fasting plasma glucose at baseline, 3 months and 6 months
measure: fasting plasma insulin at baseline, 3 months and 6 months
measure: Systolic and diastolic blod pressure at baseline, 3 months and 6 months
measure: Blood lipids at baseline, 3 months and 6 months
measure: C-reactive protein at baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University Hospital
state: Skåne
Study officials:
affiliation: Department of Clinical Sciences, Lund University, Lund Sweden
name: Tommy Jönsson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jonsson T, Ahren B, Pacini G, Sundler F, Wierup N, Steen S, Sjoberg T, Ugander M, Frostegard J, Goransson L, Lindeberg S. A Paleolithic diet confers higher insulin sensitivity, lower C-reactive protein and lower blood pressure than a cereal-based diet in domestic pigs. Nutr Metab (Lond). 2006 Nov 2;3:39. doi: 10.1186/1743-7075-3-39.
citation: Jonsson T, Olsson S, Ahren B, Bog-Hansen TC, Dole A, Lindeberg S. Agrarian diet and diseases of affluence--do evolutionary novel dietary lectins cause leptin resistance? BMC Endocr Disord. 2005 Dec 10;5:10. doi: 10.1186/1472-6823-5-10.
citation: Cordain L, Eaton SB, Sebastian A, Mann N, Lindeberg S, Watkins BA, O'Keefe JH, Brand-Miller J. Origins and evolution of the Western diet: health implications for the 21st century. Am J Clin Nutr. 2005 Feb;81(2):341-54. doi: 10.1093/ajcn.81.2.341.
citation: Fontes-Villalba M, Lindeberg S, Granfeldt Y, Knop FK, Memon AA, Carrera-Bastos P, Picazo O, Chanrai M, Sunquist J, Sundquist K, Jonsson T. Palaeolithic diet decreases fasting plasma leptin concentrations more than a diabetes diet in patients with type 2 diabetes: a randomised cross-over trial. Cardiovasc Diabetol. 2016 May 23;15:80. doi: 10.1186/s12933-016-0398-1.
citation: Jonsson T, Granfeldt Y, Ahren B, Branell UC, Palsson G, Hansson A, Soderstrom M, Lindeberg S. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009 Jul 16;8:35. doi: 10.1186/1475-2840-8-35.