Mediterranean Diet and Postprandial Lipemia

NCT00789295 | Completed

• 1 other identifier: 29102008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Postprandial Lipemia; Type 2 Diabetes

Keywords

Mediterranean diet; Postprandial lipids; Postprandial glucose; High fibre diet; Low- CHO diet; High MUFA diet; Dietary approach

Outcome Measures

Primary Outcomes (1)

• Postprandial response triglyceride of chylomicrons and large VLDL

  4 weeks

Secondary Outcomes (2)

• Blood glucose and insulin response to test meal

  4 weeks

• Lipolytic activities

  4 weeks

Study Arms (2)

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%)

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%)

Other: Mediterranean diet and Low-Carbohydrates diet

Interventions

Mediterranean diet and Low-Carbohydrates diet OTHER

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

Low-Carbohydrates diet; Mediterranean diet

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Clinical and Experimental Medicine, Federico II University Hospital,

Naples, Naples, 80100, Italy

Location

Related Publications (4)

• 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.

  PMID: 15126535 BACKGROUND

• 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.

  PMID: 17705891 BACKGROUND

• 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.

  PMID: 17079126 BACKGROUND

• 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.

  PMID: 19741188 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Gabriele Riccardi, Prof

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 11, 2008
• Study Start: March 1, 2004
• Last Updated: November 11, 2008

Record last verified: 2008-10

Locations

IT (1)