Paleolithic Diet in the Treatment of Diabetes Type 2 in Primary Health Care
NCT ID: NCT00435240
Last Updated: 2008-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2005-01-31
2007-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Interventions
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Paleolithic diet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Lund University Hospital
OTHER
Responsible Party
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Department of Clinical Sciences, Medical Faculty, Lund University Hospital, Sweden
Principal Investigators
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Tommy Jönsson, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Sciences, Lund University, Lund Sweden
Locations
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Lund University Hospital
Lund, Skåne County, Sweden
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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H4 726/2004
Identifier Type: -
Identifier Source: org_study_id