Effect of a Low Glycemic Index on Metabolic Syndrome

Metabolic Syndrome X Clinical Trial

Official title:

A Low Glycemic Index Mediterranean Diet in the Treatment of Metabolic Syndrome. A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356952
• Other study ID #: Medidiet
• Status: Completed
• Phase: N/A
• First received: January 20, 2015
• Last updated: July 25, 2016
• Start date: September 2014
• Est. completion date: August 2015

Study information

• Verified date: July 2016
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Metabolic Syndrome (MetS) is a cluster of multiple risk factors of metabolic origin associated with an increased risk of cardiovascular disease, type 2 diabetes mellitus and other diseases, including some cancers. There has been an increased interest of researchers in the relationship between MetS and diet and, specifically, Mediterranean diet would be beneficial for people with high risk of developing MetS or individuals with established MetS.

Description:

Metabolic Syndrome (MetS) is a cluster of multiple risk factors of metabolic origin, associated with an increased risk of cardiovascular disease, type 2 diabetes mellitus and other diseases, including some cancers. The National Cholesterol Education Program's Adult Treatment Panel III (NCEP-ATP III) defines MetS the presence of at least three of five diagnostic criteria consisting in the measure of waist circumference, fasting glucose, systolic pressure and/or diastolic blood pressure, serum triglycerides and HDL cholesterol. The level of physical activity, smoking habits, low social class membership as well as low level of education and even a mild degree of chronic inflammation have been associated with an increased risk of MetS. Recently, there has been an increased interest of researchers in the relationship between MetS and diet, and more specifically Mediterranean Diet (MD). A problem of the contemporary MD is the quality of carbohydrates as the foods rich in carbohydrates consumed actually, such as white bread and some type of pasta, are produced with refined flour, at high glycemic index (GI) and load (GL). There are numerous studies showing that taking large amounts of high GI and GL foods is a risk factor for coronary heart disease and type 2 diabetes. To our knowledge there is no diet trial that compared the health effects of Mediterranean diets with different quality of carbohydrates. Objective of this study was to compare, in a randomized clinical trial, the effects of a simple MD, a Low Glycemic Index diet (LGID), and a Low Glycemic Index MD (LGIMD) on MetS, MetS components and other metabolic variables. For this reason, after a baseline examination, participants were randomly divided into three groups, each receiving a specific dietary intervention, and all the parameters measured at the first visit were examined again at months third and sixth.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 89 Years

Eligibility

Inclusion Criteria:

• MetS, Subject enrolled in the MICOL study in 2005-2006

Exclusion Criteria:

• Insulin treatment, Not enrolled in the MICOL study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

Behavioral:
• Mediterranean Diet
A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
• Low Glycemic Index Diet
A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
• Low Glycemic Index Mediterranean Diet
A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).

Locations

Country	Name	City	State
Italy	Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis	Castellana Grotte	BA

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in MetS score at six months		6 months	No
Secondary	Change from Baseline in Serum Cholesterol at six months		6 months	No
Secondary	Change from Baseline in Serum HDL Cholesterol at six months		6 months	No
Secondary	Change from Baseline in Serum Triglycerides at six months		6 months	No
Secondary	Change from Baseline in Serum ALT at six months		6 months	No
Secondary	Change from Baseline in Serum Fasting Glucose at six months		6 months	No
Secondary	Change from Baseline in Serum insulin at six months		6 months	No
Secondary	Change from Baseline in Serum glycated hemoglobin at six months		6 months	No
Secondary	Change from Baseline in Systolic blood pressure at six months		6 months	No
Secondary	Change from Baseline in Diastolic blood pressure at six months		6 months	No
Secondary	Height		Baseline	No
Secondary	Change from Baseline in Body Weight at six months		6 months	No
Secondary	Change from Baseline in Bioimpedenziometry at six months		6 months	No