Metabolic Syndrome XNCT02356952
Effect of a Low Glycemic Index on Metabolic Syndrome
A study testing Mediterranean Diet, Low Glycemic Index Diet and Low Glycemic Index Mediterranean Diet in people with Metabolic Syndrome X, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 89 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Mediterranean Diet, Low Glycemic Index Diet and Low Glycemic Index Mediterranean Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MetS, Subject enrolled in the MICOL study in 2005-2006
Who cannot join
- Insulin treatment, Not enrolled in the MICOL study
Trial locations and contacts
1 site in 1 country.
Italy1 site
Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
Castellana Grotte, BA, 70013
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome X
- Being tested
- Mediterranean Diet, Low Glycemic Index Diet, Low Glycemic Index Mediterranean Diet
- Keywords
- Metabolic Syndrome X, Low Glycemic Index Mediterranean Diet, Low Glycemic Index Diet, Randomized Clinical Trial
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietBehavioural
A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
Low Glycemic Index DietBehavioural
A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
Low Glycemic Index Mediterranean DietBehavioural
A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Behavioral: Low Glycemic Index Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in MetS score at six months
Measured: 6 months
Secondary outcomes (12)
Change from Baseline in Serum Cholesterol at six months
Measured: 6 months
Change from Baseline in Serum HDL Cholesterol at six months
Measured: 6 months
Change from Baseline in Serum Triglycerides at six months
Measured: 6 months
Change from Baseline in Serum ALT at six months
Measured: 6 months
Change from Baseline in Serum Fasting Glucose at six months
Measured: 6 months
Change from Baseline in Serum insulin at six months
Measured: 6 months
Change from Baseline in Serum glycated hemoglobin at six months
Measured: 6 months
Change from Baseline in Systolic blood pressure at six months
Measured: 6 months
Change from Baseline in Diastolic blood pressure at six months
Measured: 6 months
Height
Measured: Baseline
Change from Baseline in Body Weight at six months
Measured: 6 months
Change from Baseline in Bioimpedenziometry at six months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto R Osella, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Investigators
- Alberto Rubén Osella, MD, PhD, Principal investigator, IRCCS "Saverio De Bellis"Giovanni Misciagna, MD, PhD, Study director, IRCCS "Saverio De Bellis"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356952
- Sponsor's protocol ID
- Medidiet
- Status last verified
- Jul 2016
- First submitted
- 20 Jan 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Low Glycemic Index Mediterranean Diet in the Treatment of Metabolic Syndrome. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02356952
- Acronym / sponsor ID
- Medidiet
- Conditions
- Metabolic Syndrome X
- Keywords
- Metabolic Syndrome X, Low Glycemic Index Mediterranean Diet, Low Glycemic Index Diet, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet | Experimental | Behavioral: Mediterranean DietRandomized prescription with indication about type of foods that can be consumed frequently (green foods), sometimes (yellow foods) and never (red foods). |
| Low Glycemic Index Diet | Experimental | Behavioral: Low Glycemic Index DietRandomized prescription with indication about type of foods that can be consumed frequently (green foods), sometimes (yellow foods) and never (red foods). |
| Low Glycemic Index Mediterranean Diet | Experimental | Behavioral: Low Glycemic Index Mediterranean DietRandomized prescription with indication about type of foods that can be consumed frequently (green foods), sometimes (yellow foods) and never (red foods). |
Who may qualify
- Ages
- 30 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- MetS, Subject enrolled in the MICOL study in 2005-2006
Key exclusion criteria (1 listed)
- Insulin treatment, Not enrolled in the MICOL study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean DietA list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods). | Behavioural | Mediterranean Diet |
| Low Glycemic Index DietA list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods). | Behavioural | Low Glycemic Index Diet |
| Low Glycemic Index Mediterranean DietA list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods). | Behavioural | Low Glycemic Index Mediterranean Diet |
Primary outcome
Change from Baseline in MetS score at six months
Time frame: 6 months
12 secondary outcomes
Change from Baseline in Serum Cholesterol at six months
Time frame: 6 months
Change from Baseline in Serum HDL Cholesterol at six months
Time frame: 6 months
Change from Baseline in Serum Triglycerides at six months
Time frame: 6 months
Change from Baseline in Serum ALT at six months
Time frame: 6 months
Change from Baseline in Serum Fasting Glucose at six months
Time frame: 6 months
Change from Baseline in Serum insulin at six months
Time frame: 6 months
Change from Baseline in Serum glycated hemoglobin at six months
Time frame: 6 months
Change from Baseline in Systolic blood pressure at six months
Time frame: 6 months
Change from Baseline in Diastolic blood pressure at six months
Time frame: 6 months
Height
Time frame: Baseline
Change from Baseline in Body Weight at six months
Time frame: 6 months
Change from Baseline in Bioimpedenziometry at six months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Rubén Osella, MD, PhD principal investigator
IRCCS "Saverio De Bellis"
Giovanni Misciagna, MD, PhD study director
IRCCS "Saverio De Bellis"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet, Low Glycemic Index Diet and Low Glycemic Index Mediterranean Diet in people with Metabolic Syndrome X, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in MetS score at six months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.