Postprandial LipemiaNCT00789295
Mediterranean Diet and Postprandial Lipemia
A study testing Mediterranean diet and Low-Carbohydrates diet in people with Postprandial Lipemia and Type 2 Diabetes, run by Federico II University at 1 site in Italy.
Trial summary
The aim of this intervention study was to evaluate in type 2 diabetic patients the effects on postprandial lipemia and other metabolic parameters (in both everyday life conditions and after a standard test meal) of two diets, one moderately rich in CHO, rich in fibre and with a low glycemic index (Mediterranean diet)… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Postprandial Lipemia, Type 2 Diabetes
- What is being tested?
- Mediterranean diet and Low-Carbohydrates diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Mar 2004to not given
- Phase
- Interventional
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Stable metabolic control (HbA1c<8.0%) on diet or diet alone or diet+metformin
- BMI<30 kg/m2 and body weight stable during the last six months.
- Both sexes; only post-menopausal women.
- Normal fasting lipid levels
- No use of hypolipidemic drugs
Who cannot join
- Patient with renal (serum creatinine >1.5 mg/dl) or hepatic (serum transaminases >three times upper normal values) impairment.
- Patients with history of cardiovascular disease.
- Pre-menopausal women.
- Any other acute or chronic degenerative disease.
- Anemia (Hb<12 g/dl).
- Uncontrolled blood pressure.
- Use of any drugs able to interfere with the study medications
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Clinical and Experimental Medicine, Federico II University Hospital,
Naples, Naples, 80100
About this study
Official title: Mediterranean vs. Low-Carbohydrate Diet : Which is the Best Dietary Approach for Treating Postprandial Lipid Abnormalities and Improving Glucose Control in Type 2 Diabetic Patients?
The aim of this intervention study was to evaluate in type 2 diabetic patients the effects on postprandial lipemia and other metabolic parameters (in both everyday life conditions and after a standard test meal) of two diets, one moderately rich in CHO, rich in fibre and with a low glycemic index (Mediterranean diet), and the other low in CHO and rich in MUFA (Low-CHO diet).Since adipose tissue, mainly through its lipolytic activities, is considered as having a pivotal role in the regulation of postprandial lipid metabolism, a further aim of our study was to clarify the role of adipose tissue in modulating the postprandial lipid response induced by the two dietary approaches by evaluating the activities of lipoprotein lipase (LPL) and hormone-sensitive lipase (HSL).
- Conditions
- Postprandial Lipemia, Type 2 Diabetes
- Being tested
- Mediterranean diet and Low-Carbohydrates diet
- Keywords
- Mediterranean diet, Postprandial lipids, Postprandial glucose, High fibre diet, Low- CHO diet, High MUFA diet, Dietary approach
- 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.
Mediterranean diet and Low-Carbohydrates dietOther
The Mediterranean diet: relatively rich in Carbohydrate(52% of the total daily energy intake), rich in dietary fibre (28g/1000 kcal both of soluble and unsoluble types) and with a low glycemic index (51%) versus Low-carbohydrates diet : diet rich in MUFA (23%), relatively low in CHO (45%), low in dietary fibre (8g/1000 kcal) and with a relatively high glycemic index (87%)for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet | Active comparator | The Mediterranean diet: relatively rich in Carbohydrate(52% of the total daily energy intake), rich in dietary fibre (28g/1000 kcal both of soluble and unsoluble types) and with a low glycemic index (51%) Receives: Other: Mediterranean diet and Low-Carbohydrates diet |
| Low-Carbohydrates diet | Active comparator | Low-carbohydrates diet : diet rich in MUFA (23%), relatively low in CHO (45%), low in dietary fibre (8g/1000 kcal) and with a relatively high glycemic index (87%) Receives: Other: Mediterranean diet and Low-Carbohydrates diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial response triglyceride of chylomicrons and large VLDL
Measured: 4 weeks
Secondary outcomes (2)
Blood glucose and insulin response to test meal
Measured: 4 weeks
Lipolytic activities
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postprandial LipemiaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Investigators
- Gabriele Riccardi, Prof, Study chair, Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789295
- Sponsor's protocol ID
- 29102008
- Status last verified
- Oct 2008
- First submitted
- 10 Nov 2008
- Last updated
- 11 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Rivellese AA, De Natale C, Di Marino L, Patti L, Iovine C, Coppola S, Del Prato S, Riccardi G, Annuzzi G. Exogenous and endogenous postprandial lipid abnormalities in type 2 diabetic patients with optimal blood glucose control and optimal fasting triglyceride levels. J Clin Endocrinol Metab. 2004 May;89(5):2153-9. doi: 10.1210/jc.2003-031764.
PubMed 15126535Lopez-Miranda J, Williams C, Lairon D. Dietary, physiological, genetic and pathological influences on postprandial lipid metabolism. Br J Nutr. 2007 Sep;98(3):458-73. doi: 10.1017/S000711450774268X.
PubMed 17705891Lairon D, Play B, Jourdheuil-Rahmani D. Digestible and indigestible carbohydrates: interactions with postprandial lipid metabolism. J Nutr Biochem. 2007 Apr;18(4):217-27. doi: 10.1016/j.jnutbio.2006.08.001. Epub 2006 Oct 31.
PubMed 17079126De Natale C, Annuzzi G, Bozzetto L, Mazzarella R, Costabile G, Ciano O, Riccardi G, Rivellese AA. Effects of a plant-based high-carbohydrate/high-fiber diet versus high-monounsaturated fat/low-carbohydrate diet on postprandial lipids in type 2 diabetic patients. Diabetes Care. 2009 Dec;32(12):2168-73. doi: 10.2337/dc09-0266. Epub 2009 Sep 9.
PubMed 19741188
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean vs. Low-Carbohydrate Diet : Which is the Best Dietary Approach for Treating Postprandial Lipid Abnormalities and Improving Glucose Control in Type 2 Diabetic Patients?
- ClinicalTrials.gov ID
- NCT00789295
- Acronym / sponsor ID
- 29102008
- Conditions
- Postprandial Lipemia, Type 2 Diabetes
- Keywords
- Mediterranean diet, Postprandial lipids, Postprandial glucose, High fibre diet, Low- CHO diet, High MUFA diet, Dietary approach
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Mar 2004
- First posted
- 11 Nov 2008 (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 aim of this intervention study was to evaluate in type 2 diabetic patients the effects on postprandial lipemia and other metabolic parameters (in both everyday life conditions and after a standard test meal) of two diets, one moderately rich in CHO, rich in fibre and with a low glycemic index (Mediterranean diet), and the other low in CHO and rich in MUFA (Low-CHO diet).Since adipose tissue, mainly through its lipolytic activities, is considered as having a pivotal role in the regulation of postprandial lipid metabolism, a further aim of our study was to clarify the role of adipose tissue in modulating the postprandial lipid response induced by the two dietary approaches by evaluating the activities of lipoprotein lipase (LPL) and hormone-sensitive lipase (HSL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet | Active comparator | Other: Mediterranean diet and Low-Carbohydrates dietThe Mediterranean diet: relatively rich in Carbohydrate(52% of the total daily energy intake), rich in dietary fibre (28g/1000 kcal both of soluble and unsoluble types) and with a low glycemic index (51%) |
| Low-Carbohydrates diet | Active comparator | Other: Mediterranean diet and Low-Carbohydrates dietLow-carbohydrates diet : diet rich in MUFA (23%), relatively low in CHO (45%), low in dietary fibre (8g/1000 kcal) and with a relatively high glycemic index (87%) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes
- Stable metabolic control (HbA1c<8.0%) on diet or diet alone or diet+metformin
- BMI<30 kg/m2 and body weight stable during the last six months.
- Both sexes; only post-menopausal women.
- Normal fasting lipid levels
Key exclusion criteria (7 listed)
- Patient with renal (serum creatinine >1.5 mg/dl) or hepatic (serum transaminases >three times upper normal values) impairment.
- Patients with history of cardiovascular disease.
- Pre-menopausal women.
- Any other acute or chronic degenerative disease.
- Anemia (Hb<12 g/dl).
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 |
|---|---|---|
| Mediterranean diet and Low-Carbohydrates dietThe Mediterranean diet: relatively rich in Carbohydrate(52% of the total daily energy intake), rich in dietary fibre (28g/1000 kcal both of soluble and unsoluble types) and with a low glycemic index (51%) versus Low-carbohydrates diet : diet rich in MUFA (23%), relatively low in CHO (45%), low in dietary fibre (8g/1000 kcal) and with a relatively high glycemic index (87%)for 4 weeks | Other | Low-Carbohydrates diet, Mediterranean diet |
Primary outcome
Postprandial response triglyceride of chylomicrons and large VLDL
Time frame: 4 weeks
2 secondary outcomes
Blood glucose and insulin response to test meal
Time frame: 4 weeks
Lipolytic activities
Time frame: 4 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 11 Nov 2008.
- Background: PubMed 15126535Rivellese AA, De Natale C, Di Marino L, Patti L, Iovine C, Coppola S, Del Prato S, Riccardi G, Annuzzi G. Exogenous and endogenous postprandial lipid abnormalities in type 2 diabetic patients with optimal blood glucose control and optimal fasting triglyceride levels. J Clin Endocrinol Metab. 2004 May;89(5):2153-9. doi: 10.1210/jc.2003-031764.
- Background: PubMed 17705891Lopez-Miranda J, Williams C, Lairon D. Dietary, physiological, genetic and pathological influences on postprandial lipid metabolism. Br J Nutr. 2007 Sep;98(3):458-73. doi: 10.1017/S000711450774268X.
- Background: PubMed 17079126Lairon D, Play B, Jourdheuil-Rahmani D. Digestible and indigestible carbohydrates: interactions with postprandial lipid metabolism. J Nutr Biochem. 2007 Apr;18(4):217-27. doi: 10.1016/j.jnutbio.2006.08.001. Epub 2006 Oct 31.
- Derived from this study: PubMed 19741188De Natale C, Annuzzi G, Bozzetto L, Mazzarella R, Costabile G, Ciano O, Riccardi G, Rivellese AA. Effects of a plant-based high-carbohydrate/high-fiber diet versus high-monounsaturated fat/low-carbohydrate diet on postprandial lipids in type 2 diabetic patients. Diabetes Care. 2009 Dec;32(12):2168-73. doi: 10.2337/dc09-0266. Epub 2009 Sep 9.
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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.
Gabriele Riccardi, Prof study chair
Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet and Low-Carbohydrates diet in people with Postprandial Lipemia and Type 2 Diabetes, run by Federico II University at 1 site in Italy.
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 6 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 11 Nov 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 Italy. 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.
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?
Postprandial response triglyceride of chylomicrons and large VLDL (time frame: 4 weeks). 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 NCT00789295, which also lists 4 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 11 Nov 2008.