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Mediterranean Diet and Postprandial Lipemia

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00789295
First received: November 10, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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).


Condition Intervention
Postprandial Lipemia
Type 2 Diabetes
 Other: Mediterranean diet and Low-Carbohydrates diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Postprandial response triglyceride of chylomicrons and large VLDL [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Blood glucose and insulin response to test meal [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Lipolytic activities [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Study Start Date: March 2004
Arms Assigned Interventions
Active Comparator: Mediterranean diet
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%)
 Other: Mediterranean diet and Low-Carbohydrates diet
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
Active Comparator: Low-Carbohydrates diet
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%)
 Other: Mediterranean diet and Low-Carbohydrates diet
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

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789295

Locations
Italy
Department of Clinical and Experimental Medicine, Federico II University Hospital,
Naples, Italy, 80100
Sponsors and Collaborators
Federico II University
Investigators
Study Chair: Gabriele Riccardi, Prof Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Angela A. Rivellese, MD, Department of Clinical and Experimental Medicine Federico II University Naples
ClinicalTrials.gov Identifier: NCT00789295     History of Changes
Other Study ID Numbers: 29102008
Study First Received: November 10, 2008
Last Updated: November 10, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
Mediterranean diet
Postprandial lipids
Postprandial glucose
High fibre diet
 Low- CHO diet
High MUFA diet
Dietary approach

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hyperlipidemias
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 16, 2013