Effect of a Low Glycemic Index on Metabolic Syndrome

NCT ID: NCT02356952

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-08-31

Brief 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.

Detailed 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.

Conditions

Metabolic Syndrome X

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mediterranean Diet

Randomized prescription with indication about type of foods that can be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).

Group Type: EXPERIMENTAL

Mediterranean Diet

Intervention Type: BEHAVIORAL

A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).

Low Glycemic Index Diet

Randomized prescription with indication about type of foods that can be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).

Group Type: EXPERIMENTAL

Low Glycemic Index Diet

Intervention Type: BEHAVIORAL

A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).

Low Glycemic Index Mediterranean Diet

Randomized prescription with indication about type of foods that can be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).

Group Type: EXPERIMENTAL

Low Glycemic Index Mediterranean Diet

Intervention Type: BEHAVIORAL

A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).

Interventions

Mediterranean Diet

A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).

Intervention Type: BEHAVIORAL

Low Glycemic Index Diet

A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).

Intervention Type: BEHAVIORAL

Low Glycemic Index Mediterranean Diet

A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Insulin treatment, Not enrolled in the MICOL study

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

OTHER

Sponsor Role: lead

Responsible Party

Alberto R Osella

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto Rubén Osella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS "Saverio De Bellis"

Giovanni Misciagna, MD, PhD

Role: STUDY_DIRECTOR

IRCCS "Saverio De Bellis"

Locations

Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis

Castellana Grotte, BA, Italy

Countries

Italy

Other Identifiers

Medidiet

Identifier Type: -

Identifier Source: org_study_id