HyperglycemiaPhase 2/3NCT00419497
Paleolithic Diet in the Treatment of Glucose Intolerance
A Phase 2/3 study testing Paleolithic diet vs Mediterranean diet in people with Hyperglycemia and Coronary Heart Disease, run by Lund University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether a paleolithic diet improves glucose tolerance and insulin sensitivity in people with coronary heart disease and impaired glucose tolerance. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hyperglycemia, Coronary Heart Disease
- What is being tested?
- Paleolithic diet vs Mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2003to Jun 2007
- Phase
- Phase 2/3
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hyperglycemia
- Coronary Heart Disease
- Increased waist circumference
Who cannot join
- Body mass index <20 kg/m2
- Serum creatinine >130 µmol/L
- Poor general condition
- Dementia
- Unwillingness/inability to prepare food at home (by study participant or partner)
- Participation in another medical trial
Show all 10Show fewer
- Chronic inflammatory bowel disease
- Drug treatment with hypoglycemic agents
- Drug treatment with warfarin
- Drug treatment with oral steroid
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether a paleolithic diet improves glucose tolerance and insulin sensitivity in people with coronary heart disease and impaired glucose tolerance.
Read the detailed description
There is uncertainty about the optimal diet in the prevention and treatment of glucose intolerance and diabetes type 2, disorders which are very common in patients with coronary heart disease (CHD). Earlier studies have generally focused on intakes of fat, carbohydrate, fiber, fruit and vegetables. Another approach compares foods that were available during human evolution with more recently introduced ones. Twenty-nine CHD patients with glucose intolerance or diabetes have been randomized to 1) a Paleolithic ("Old Stone Age") diet (n=14) based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts, or 2) a Consensus (Mediterranean-like) diet (n=15) based on whole grains, low-fat dairy products, vegetables, fruit, fish, and oils and margarines generally assumed to be healthy. Primary outcome variables are changes during 12 weeks in weight, waist circumference, and area under the curve for glucose (AUC Glucose0-120) and insulin (AUC Insulin0-120) at the oral glucose tolerance test.
- Conditions
- Hyperglycemia, Coronary Heart Disease
- Being tested
- Paleolithic diet vs Mediterranean diet
- Keywords
- Paleolithic diet, Mediterranean-style diet, Glucose tolerance, Diabetes type 2, Weight loss, Waist
- Medical subject headings
- Hyperglycemia, Coronary Disease, Diabetes Mellitus, Type 2, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paleolithic diet vs Mediterranean dietBehavioural
Prudent diets with or without grains and dairy
| Study group | Role | What they receive |
|---|---|---|
| Paleolithic diet vs Mediterranean diet | Active comparator | Prudent diets with or without grains and dairy Receives: Behavioral: Paleolithic diet vs Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in weight and waist circumference
Measured: 12 weeks
area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test
Measured: 12 weeks
area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test
Measured: 12 weeks
Secondary outcomes (6)
fasting plasma glucose
Measured: 12 weeks
30-min plasma glucose
Measured: 12 weeks
120-min plasma glucose
Measured: 12 weeks
fasting plasma insulin
Measured: 12 weeks
30-min plasma insulin
Measured: 12 weeks
120-min plasma insulin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startJan 2003
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Staffan Lindeberg, Lund University Hospital
- Investigators
- Staffan Lindeberg, MD PhD, Principal investigator, Department of Clinical Sciences, IKVL 1, Lund University, Lund Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419497
- Sponsor's protocol ID
- LU 665-02
- Status last verified
- Sep 2016
- First submitted
- 4 Jan 2007
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lindeberg S, Jonsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjostrom K, Ahren B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-1807. doi: 10.1007/s00125-007-0716-y. Epub 2007 Jun 22.
PubMed 17583796Jonsson T, Granfeldt Y, Erlanson-Albertsson C, Ahren B, Lindeberg S. A paleolithic diet is more satiating per calorie than a mediterranean-like diet in individuals with ischemic heart disease. Nutr Metab (Lond). 2010 Nov 30;7:85. doi: 10.1186/1743-7075-7-85.
PubMed 21118562
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paleolithic Diet in the Treatment of Glucose Intolerance
- ClinicalTrials.gov ID
- NCT00419497
- Acronym / sponsor ID
- LU 665-02
- Conditions
- Hyperglycemia, Coronary Heart Disease
- Keywords
- Paleolithic diet, Mediterranean-style diet, Glucose tolerance, Diabetes type 2, Weight loss, Waist
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 8 Jan 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.
The purpose of this study is to determine whether a paleolithic diet improves glucose tolerance and insulin sensitivity in people with coronary heart disease and impaired glucose tolerance.
Detailed description
There is uncertainty about the optimal diet in the prevention and treatment of glucose intolerance and diabetes type 2, disorders which are very common in patients with coronary heart disease (CHD). Earlier studies have generally focused on intakes of fat, carbohydrate, fiber, fruit and vegetables. Another approach compares foods that were available during human evolution with more recently introduced ones. Twenty-nine CHD patients with glucose intolerance or diabetes have been randomized to 1) a Paleolithic ("Old Stone Age") diet (n=14) based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts, or 2) a Consensus (Mediterranean-like) diet (n=15) based on whole grains, low-fat dairy products, vegetables, fruit, fish, and oils and margarines generally assumed to be healthy. Primary outcome variables are changes during 12 weeks in weight, waist circumference, and area under the curve for glucose (AUC Glucose0-120) and insulin (AUC Insulin0-120) at the oral glucose tolerance test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paleolithic diet vs Mediterranean diet | Active comparator | Behavioral: Paleolithic diet vs Mediterranean dietPrudent diets with or without grains and dairy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Hyperglycemia
- Coronary Heart Disease
- Increased waist circumference
Key exclusion criteria (10 listed)
- Body mass index <20 kg/m2
- Serum creatinine >130 µmol/L
- Poor general condition
- Dementia
- Unwillingness/inability to prepare food at home (by study participant or partner)
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 vs Mediterranean dietPrudent diets with or without grains and dairy | Behavioural | Paleolithic diet vs Mediterranean diet |
Primary outcome
change in weight and waist circumference
Time frame: 12 weeks
area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test
Time frame: 12 weeks
area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test
Time frame: 12 weeks
6 secondary outcomes
fasting plasma glucose
Time frame: 12 weeks
30-min plasma glucose
Time frame: 12 weeks
120-min plasma glucose
Time frame: 12 weeks
fasting plasma insulin
Time frame: 12 weeks
30-min plasma insulin
Time frame: 12 weeks
120-min plasma insulin
Time frame: 12 weeks
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 20 Sep 2016.
- Results publication: PubMed 17583796Lindeberg S, Jonsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjostrom K, Ahren B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-1807. doi: 10.1007/s00125-007-0716-y. Epub 2007 Jun 22.
- Derived from this study: PubMed 21118562Jonsson T, Granfeldt Y, Erlanson-Albertsson C, Ahren B, Lindeberg S. A paleolithic diet is more satiating per calorie than a mediterranean-like diet in individuals with ischemic heart disease. Nutr Metab (Lond). 2010 Nov 30;7:85. doi: 10.1186/1743-7075-7-85.
- Individual participant dataSharing planned: No
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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.
Staffan Lindeberg, MD PhD principal investigator
Department of Clinical Sciences, IKVL 1, 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 2/3 study testing Paleolithic diet vs Mediterranean diet in people with Hyperglycemia and Coronary Heart Disease, 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 3 inclusion and 10 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 20 Sep 2016. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
change in weight and waist circumference (time frame: 12 weeks). The study lists 3 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 NCT00419497, which also lists 2 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 20 Sep 2016.