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

NCT00435240 | Completed Phase 2

• 1 other identifier: H4 726/2004
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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. 1.a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts
2. 2.a standard diabetes diet as recommended by national health authorities.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• satiation measured on visual semi-analogous scale at food intake during 4 days av 6 weeks and 12 weeks

• 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

Interventions

Paleolithic diet BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (1)

Lund University Hospital

Lund, Skåne County, 22185, Sweden

Location

Related Publications (6)

• 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.

  PMID: 17081292 BACKGROUND

• 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.

  PMID: 16336696 BACKGROUND

• 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.

  PMID: 15699220 BACKGROUND

• Fontes-Villalba M, Granfeldt Y, Sundquist K, Memon AA, Hedelius A, Carrera-Bastos P, Jonsson T. Effects of a Paleolithic diet compared to a diabetes diet on leptin binding inhibition in secondary analysis of a randomised cross-over study. BMC Endocr Disord. 2024 Sep 4;24(1):176. doi: 10.1186/s12902-024-01715-0.

  PMID: 39232748 DERIVED

• 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.

  PMID: 27216013 DERIVED

• 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.

  PMID: 19604407 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Paleolithic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Tommy Jönsson, MD

  Department of Clinical Sciences, Lund University, Lund Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2007
• First Posted: February 14, 2007
• Study Start: January 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 15, 2008

Record last verified: 2008-05

Locations

SE (1)