Effect of a Low Glycemic Index on Metabolic Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome X
• Intervention / Treatment: Behavioral: Mediterranean Diet; Behavioral: Low Glycemic Index Diet; Behavioral: Low Glycemic Index Mediterranean Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BA
    • Castellana Grotte, BA, Italy, 70013
      • Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Insulin treatment, Not enrolled in the MICOL study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean Diet; Randomized prescription with indication about type of foods that can be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).	Behavioral: Mediterranean Diet; A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
Experimental: 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).	Behavioral: Low Glycemic Index Diet; A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
Experimental: 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).	Behavioral: Low Glycemic Index Mediterranean Diet; A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in MetS score at six months	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Height	Baseline
Change from Baseline in Serum Cholesterol at six months	6 months
Change from Baseline in Serum HDL Cholesterol at six months	6 months
Change from Baseline in Serum Triglycerides at six months	6 months
Change from Baseline in Serum ALT at six months	6 months
Change from Baseline in Serum Fasting Glucose at six months	6 months
Change from Baseline in Serum insulin at six months	6 months
Change from Baseline in Serum glycated hemoglobin at six months	6 months
Change from Baseline in Systolic blood pressure at six months	6 months
Change from Baseline in Diastolic blood pressure at six months	6 months
Change from Baseline in Body Weight at six months	6 months
Change from Baseline in Bioimpedenziometry at six months	6 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Investigators: Principal Investigator: Alberto Rubén Osella, MD, PhD, IRCCS "Saverio de Bellis"; Study Director: Giovanni Misciagna, MD, PhD, IRCCS "Saverio de Bellis"

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: February 2, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Randomized Clinical Trial; Metabolic Syndrome X; Low Glycemic Index Mediterranean Diet; Low Glycemic Index Diet
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Angina Pectoris; Syndrome; Metabolic Syndrome; Microvascular Angina
• Other Study ID Numbers: Medidiet

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided