NCT02356952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

January 20, 2015

Last Update Submit

July 25, 2016

Conditions

Metabolic Syndrome X

Keywords

Metabolic Syndrome XLow Glycemic Index Mediterranean DietLow Glycemic Index DietRandomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in MetS score at six months

    6 months

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (3)

Mediterranean Diet

EXPERIMENTAL

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

Low Glycemic Index Diet

EXPERIMENTAL

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

Low Glycemic Index Mediterranean Diet

EXPERIMENTAL

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

Interventions

Mediterranean DietBEHAVIORAL

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

Mediterranean Diet
Low Glycemic Index DietBEHAVIORAL

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

Low Glycemic Index Diet
Low Glycemic Index Mediterranean DietBEHAVIORAL

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

Low Glycemic Index Mediterranean Diet

Eligibility Criteria

Age30 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Insulin treatment, Not enrolled in the MICOL study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis

Castellana Grotte, BA, 70013, Italy

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Alberto Rubén Osella, MD, PhD

    IRCCS "Saverio De Bellis"

    PRINCIPAL INVESTIGATOR

  • Giovanni Misciagna, MD, PhD

    IRCCS "Saverio De Bellis"

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 20, 2015

First Posted

February 6, 2015

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

IT(1)