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Effect of a Low Glycemic Index on Metabolic Syndrome

Primary Purpose

Metabolic Syndrome X

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Mediterranean Diet
Low Glycemic Index Diet
Low Glycemic Index Mediterranean Diet
Sponsored by
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring Metabolic Syndrome X, Low Glycemic Index Mediterranean Diet, Low Glycemic Index Diet, Randomized Clinical Trial

Eligibility Criteria

30 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Insulin treatment, Not enrolled in the MICOL study

Sites / Locations

  • Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Mediterranean Diet

Low Glycemic Index Diet

Low Glycemic Index Mediterranean Diet

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change from Baseline in MetS score at six months

Secondary Outcome Measures

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

Full Information

First Posted
January 20, 2015
Last Updated
July 25, 2016
Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
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1. Study Identification

Unique Protocol Identification Number
NCT02356952
Brief Title
Effect of a Low Glycemic Index on Metabolic Syndrome
Official Title
A Low Glycemic Index Mediterranean Diet in the Treatment of Metabolic Syndrome. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
Metabolic Syndrome X, Low Glycemic Index Mediterranean Diet, Low Glycemic Index Diet, Randomized Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
Randomized prescription with indication about type of foods that can be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
Arm Title
Low Glycemic Index Diet
Arm Type
Experimental
Arm Description
Randomized prescription with indication about type of foods that can be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
Arm Title
Low Glycemic Index Mediterranean Diet
Arm Type
Experimental
Arm Description
Randomized prescription with indication about type of foods that can be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean Diet
Intervention Description
A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
Intervention Type
Behavioral
Intervention Name(s)
Low Glycemic Index Diet
Intervention Description
A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
Intervention Type
Behavioral
Intervention Name(s)
Low Glycemic Index Mediterranean Diet
Intervention Description
A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
Primary Outcome Measure Information:
Title
Change from Baseline in MetS score at six months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Serum Cholesterol at six months
Time Frame
6 months
Title
Change from Baseline in Serum HDL Cholesterol at six months
Time Frame
6 months
Title
Change from Baseline in Serum Triglycerides at six months
Time Frame
6 months
Title
Change from Baseline in Serum ALT at six months
Time Frame
6 months
Title
Change from Baseline in Serum Fasting Glucose at six months
Time Frame
6 months
Title
Change from Baseline in Serum insulin at six months
Time Frame
6 months
Title
Change from Baseline in Serum glycated hemoglobin at six months
Time Frame
6 months
Title
Change from Baseline in Systolic blood pressure at six months
Time Frame
6 months
Title
Change from Baseline in Diastolic blood pressure at six months
Time Frame
6 months
Title
Height
Time Frame
Baseline
Title
Change from Baseline in Body Weight at six months
Time Frame
6 months
Title
Change from Baseline in Bioimpedenziometry at six months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: MetS, Subject enrolled in the MICOL study in 2005-2006 Exclusion Criteria: Insulin treatment, Not enrolled in the MICOL study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Rubén Osella, MD, PhD
Organizational Affiliation
IRCCS "Saverio De Bellis"
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giovanni Misciagna, MD, PhD
Organizational Affiliation
IRCCS "Saverio De Bellis"
Official's Role
Study Director
Facility Information:
Facility Name
Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
City
Castellana Grotte
State/Province
BA
ZIP/Postal Code
70013
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of a Low Glycemic Index on Metabolic Syndrome

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