Clinical trial NCT02356952: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Keywords: Metabolic Syndrome X
Low Glycemic Index Mediterranean Diet
Low Glycemic Index Diet
Randomized Clinical Trial
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 163
Sex: ALL
Minimum age (years): 30
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Insulin treatment, Not enrolled in the MICOL study

Primary outcomes:
measure: Change from Baseline in MetS score at six months
timeFrame: 6 months
Secondary outcomes:
measure: Change from Baseline in Serum Cholesterol at six months
timeFrame: 6 months
measure: Change from Baseline in Serum HDL Cholesterol at six months
timeFrame: 6 months
measure: Change from Baseline in Serum Triglycerides at six months
timeFrame: 6 months
measure: Change from Baseline in Serum ALT at six months
timeFrame: 6 months
measure: Change from Baseline in Serum Fasting Glucose at six months
timeFrame: 6 months
measure: Change from Baseline in Serum insulin at six months
timeFrame: 6 months
measure: Change from Baseline in Serum glycated hemoglobin at six months
timeFrame: 6 months
measure: Change from Baseline in Systolic blood pressure at six months
timeFrame: 6 months
measure: Change from Baseline in Diastolic blood pressure at six months
timeFrame: 6 months
measure: Height
timeFrame: Baseline
measure: Change from Baseline in Body Weight at six months
timeFrame: 6 months
measure: Change from Baseline in Bioimpedenziometry at six months
timeFrame: 6 months
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
state: BA
Study officials:
affiliation: IRCCS "Saverio De Bellis"
name: Alberto Rubén Osella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS "Saverio De Bellis"
name: Giovanni Misciagna, MD, PhD
role: STUDY_DIRECTOR
References: