Back to resultsMediterranean Diet and Postprandial Lipemia
Primary Purpose
Postprandial Lipemia, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Mediterranean diet and Low-Carbohydrates diet
Sponsored by
About this trial
This is an interventional treatment trial for Postprandial Lipemia focused on measuring Mediterranean diet, Postprandial lipids, Postprandial glucose, High fibre diet, Low- CHO diet, High MUFA diet, Dietary approach
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Department of Clinical and Experimental Medicine, Federico II University Hospital,
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mediterranean diet
Low-Carbohydrates diet
Arm Description
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%)
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%)
Outcomes
Primary Outcome Measures
Postprandial response triglyceride of chylomicrons and large VLDL
Secondary Outcome Measures
Blood glucose and insulin response to test meal
Lipolytic activities
Full Information
NCT ID
NCT00789295
First Posted
November 10, 2008
Last Updated
November 10, 2008
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT00789295
Brief Title
Mediterranean Diet and Postprandial Lipemia
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?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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), 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Lipemia, Type 2 Diabetes
Keywords
Mediterranean diet, Postprandial lipids, Postprandial glucose, High fibre diet, Low- CHO diet, High MUFA diet, Dietary approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
Mediterranean diet
Arm Type
Active Comparator
Arm Description
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%)
Arm Title
Low-Carbohydrates diet
Arm Type
Active Comparator
Arm Description
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%)
Intervention Type
Other
Intervention Name(s)
Mediterranean diet and Low-Carbohydrates diet
Intervention Description
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
Primary Outcome Measure Information:
Title
Postprandial response triglyceride of chylomicrons and large VLDL
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Blood glucose and insulin response to test meal
Time Frame
4 weeks
Title
Lipolytic activities
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriele Riccardi, Prof
Organizational Affiliation
Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Clinical and Experimental Medicine, Federico II University Hospital,
City
Naples
ZIP/Postal Code
80100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
15126535
Citation
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.
Results Reference
background
PubMed Identifier
17705891
Citation
Lopez-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.
Results Reference
background
PubMed Identifier
17079126
Citation
Lairon 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.
Results Reference
background
PubMed Identifier
19741188
Citation
De 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.
Results Reference
derived
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Mediterranean Diet and Postprandial Lipemia
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