Mediterranean Diet and Postprandial Lipemia

Not Applicable

Completed

• Conditions: Postprandial Lipemia; Type 2 Diabetes
• Interventions: Other: Mediterranean diet and Low-Carbohydrates diet

• Registration Number: NCT00789295
• Lead Sponsor: Federico II University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Status Verified: 2008-10
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-10
• Last Update Submitted: 2008-11-10
• Study First Posted: 2008-11-11
• Last Update Posted: 2008-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mediterranean diet	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%)
Low-Carbohydrates diet	Mediterranean diet and 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%)

Primary Outcome Measures

Name	Time	Method
Postprandial response triglyceride of chylomicrons and large VLDL	4 weeks

Secondary Outcome Measures

Name	Time	Method
Blood glucose and insulin response to test meal	4 weeks
Lipolytic activities	4 weeks

Trial Locations

Locations (1)

Department of Clinical and Experimental Medicine, Federico II University Hospital,; 🇮🇹 Naples, Italy