Effect of a Low Glycemic Index on Metabolic Syndrome

July 25, 2016 updated by: Alberto R Osella, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
163

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in MetS score at six months
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Height
Time Frame: Baseline
Baseline
Change from Baseline in Serum Cholesterol at six months
Time Frame: 6 months
6 months
Change from Baseline in Serum HDL Cholesterol at six months
Time Frame: 6 months
6 months
Change from Baseline in Serum Triglycerides at six months
Time Frame: 6 months
6 months
Change from Baseline in Serum ALT at six months
Time Frame: 6 months
6 months
Change from Baseline in Serum Fasting Glucose at six months
Time Frame: 6 months
6 months
Change from Baseline in Serum insulin at six months
Time Frame: 6 months
6 months
Change from Baseline in Serum glycated hemoglobin at six months
Time Frame: 6 months
6 months
Change from Baseline in Systolic blood pressure at six months
Time Frame: 6 months
6 months
Change from Baseline in Diastolic blood pressure at six months
Time Frame: 6 months
6 months
Change from Baseline in Body Weight at six months
Time Frame: 6 months
6 months
Change from Baseline in Bioimpedenziometry at six months
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alberto Rubén Osella, MD, PhD, IRCCS "Saverio de Bellis"
  • Study Director: Giovanni Misciagna, MD, PhD, IRCCS "Saverio de Bellis"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Medidiet

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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