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Completed

NCT Number: NCT02356952

Effect of a Low Glycemic Index on Metabolic Syndrome

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.

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Key information

Conditions

Metabolic Syndrome X Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

30 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis

Castellana Grotte, BA, 70013, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Insulin treatment, Not enrolled in the MICOL study

Treatment and study plan

Mediterranean Diet

Behavioral

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

Low glycemic index diet

Behavioral

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

Low Glycemic Index Mediterranean Diet

Behavioral

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

Primary outcomes

  1. Change from Baseline in MetS score at six months

    Time frame: 6 months

Secondary outcomes

  1. Change from Baseline in Serum Cholesterol at six months

    Time frame: 6 months

  2. Change from Baseline in Serum HDL Cholesterol at six months

    Time frame: 6 months

  3. Change from Baseline in Serum Triglycerides at six months

    Time frame: 6 months

  4. Change from Baseline in Serum ALT at six months

    Time frame: 6 months

  5. Change from Baseline in Serum Fasting Glucose at six months

    Time frame: 6 months

  6. Change from Baseline in Serum insulin at six months

    Time frame: 6 months

  7. Change from Baseline in Serum glycated hemoglobin at six months

    Time frame: 6 months

  8. Change from Baseline in Systolic blood pressure at six months

    Time frame: 6 months

  9. Change from Baseline in Diastolic blood pressure at six months

    Time frame: 6 months

  10. Height

    Time frame: Baseline

  11. Change from Baseline in Body Weight at six months

    Time frame: 6 months

  12. Change from Baseline in Bioimpedenziometry at six months

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2015
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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