Diabetes Mellitus, Type 2Phase 2NCT00435240
Paleolithic Diet in the Treatment of Diabetes Type 2 in Primary Health Care
A Phase 2 study testing Paleolithic diet in people with Diabetes Mellitus, Type 2, run by Lund University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Paleolithic diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2005to Sep 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- No acute heart disease during last 6 months
- Unchanged treatment with betablocker last 6 months
- Unchanged treatment with thyroid hormone substitution last 6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
- a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts
- 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Paleolithic diet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paleolithic dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Blood lipids at baseline, 3 months and 6 months
C-reactive protein at baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startJan 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tommy Jönsson, MD, Principal investigator, Department of Clinical Sciences, Lund University, Lund Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435240
- Sponsor's protocol ID
- H4 726/2004
- Status last verified
- May 2008
- First submitted
- 13 Feb 2007
- Last updated
- 15 May 2008
- Results posted
- No
Publications
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.
PubMed 17081292Jonsson 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.
PubMed 16336696Cordain 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.
PubMed 15699220Fontes-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.
PubMed 39232748Fontes-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.
PubMed 27216013Jonsson 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.
PubMed 19604407
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paleolithic Diet in the Treatment of Diabetes Type 2 in Primary Health Care
- ClinicalTrials.gov ID
- NCT00435240
- Acronym / sponsor ID
- H4 726/2004
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 14 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults with capacity to perform study
- Diabetes Mellitus Type 2
- C-peptide > 0
- HbA1C >5.5
- Unchanged diabetes treatment during last 3 months
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paleolithic diet | Behavioural | – |
Primary outcome
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
7 secondary outcomes
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
Blood lipids at baseline, 3 months and 6 months
C-reactive protein at baseline, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2008.
- Background: PubMed 17081292Jonsson 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.
- Background: PubMed 16336696Jonsson 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.
- Background: PubMed 15699220Cordain 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.
- Derived from this study: PubMed 39232748Fontes-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.
- Derived from this study: PubMed 27216013Fontes-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.
- Derived from this study: PubMed 19604407Jonsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tommy Jönsson, MD principal investigator
Department of Clinical Sciences, Lund University, Lund Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paleolithic diet in people with Diabetes Mellitus, Type 2, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00435240, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2008.