NAFLDNCT02347696
Diet and Physical Activity on NAFLD and Erytrocyte Membrane Lipid Profile.
A study testing LGIMD, Endurance Activity (EA) and EA+Resistance Training (RT) in people with NAFLD, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial summary
This study aims to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index Mediterranean Diet and of the interaction of both, on NAFLD score and on the lipid composition of the erythrocyte membrane. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- NAFLD
- What is being tested?
- LGIMD, Endurance Activity (EA) and EA+Resistance Training (RT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2015to Dec 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI ≥ 25.0
- Moderate or severe NAFLD
- 30 < age <60
Who cannot join
- Overt cardiovascular disease and revascularization procedures;
- Stroke;
- Clinical peripheral artery disease;
- Type-2 Diabetes Mellitus (current treatment with insulin or oral hypoglycemic drugs, fasting glucose >126 mg/dl, or casual glucose >200 mg/dl);
- Severe medical condition that may impair the person to participate in a nutritional intervention study;
- Impossibility to follow Mediterranean Diet for religious or other reasons.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
Castellana Grotte, BA, 70013
Isabella Franco, BSc, 00390804994650, isabella.franco@irccsdebellis.it
About this study
Official title: Effect of Two Programs of Physical Activity of Different Intensity, Mediterranean Diet and the Combination of Both on NAFLD and Erytrocyte Membrane Lipid Profile.
This study aims to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index Mediterranean Diet and of the interaction of both, on NAFLD score and on the lipid composition of the erythrocyte membrane.
Read the detailed description
The surveys conducted on the populations of Castellana Grotte and Putignano (Bari, Italy) evidenced that Non-Alcoholic Fatty liver Disease (NAFLD) reaches a prevalence of 30%, especially among aged and male individuals. Being a crucial outcome of several metabolic alterations, it becomes imperative for Public Health to adopt strategies aimed to control the factors responsible for NAFLD onset.
The objective of this study is to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index Mediterranean Diet and of the interaction of both, on NAFLD score and on the lipid composition of the erythrocyte membrane.
Study participants responding to the inclusion criteria of this trial will be chosen both in the hospital setting and in the general practitioners' clinics. At the enrollement, anthropometric and biochemical variables will be measured, as well as bioimpedenziometric and calorimetric parameters; participants will also undergo Fibroscan-CAP to measure the outcome and will be asked about their medical history and life-style. Subjects will be randomized to the different arms of the trial and be followed-up at the end of the sixth and the twelfth week of enrollement.
All data will be statistically analysed by applying the Chi-Square test and t-test for discrete and continuous variables, respectively. As it deals with the analysis of data repeatedly measured on the same subject, the Generalized Estimating Equation (GEE) will be applied to evaluate the effect of the intervention on the outcomes.
- Conditions
- NAFLD
- Being tested
- Control, LGIMD, Endurance Activity (EA), EA+Resistance Training (RT), LGIMD+EA
- Keywords
- Diet, Physical Activity, Trial, Lipidomics, Occidental Diseases
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Subjects will follow a diet based on INRAN guidelines without doing any physical activity.
LGIMDBehavioural
Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity.
Endurance Activity (EA)Behavioural
Subject will follow a program of endurance activity as follows:
Frequency: 3 times/week Duration: 60 minutes
Intensity:
- weeks 1-4: 14.2 kcal*kg-1*week-1;
- weeks 5-8: 18.9 kcal*kg-1*week-1;
- weeks 9-12: 23.6 kcal*kg-1*week-1.
EA+Resistance Training (RT)Behavioural
Subject will follow a program of endurance activity as follows:
Frequency: 3 times/week Duration: 60 minutes
Intensity (for Endurance activity):
- weeks 1-4: 14.2 kcal*kg-1*week-1;
- weeks 5-8: 18.9 kcal*kg-1*week-1;
- weeks 9-12: 23.6 kcal*kg-1*week-1.
Resistance activity:
Muscolation: Training of the bigger muscle groups (chest, shoulders, arms, abdomen, back, glutes and legs);
- Progression: increase of 1-2.5 kg*week-1
- Training of all muscle groups in the same session
LGIMD+EABehavioural
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity.
LGIMD+EA/RTBehavioural
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | The subjects will follow a diet based on INRAN guidelines without doing any physical activity. Receives: Behavioral: Control |
| LGIMD | Other | The subjects will follow a Low Glycemic Index Mediterranean Diet without doing any physical activity. Receives: Behavioral: LGIMD |
| Endurance Activity (EA) | Other | The subjects will follow a program of endurance (aerobic) activity (EA) without following a specific diet. Receives: Behavioral: Endurance Activity (EA) |
| EA+Resistance Training (RT) | Other | The subjects will follow a program of endurance activity (EA) and resistance training (RT) without following a specific diet. Receives: Behavioral: EA+Resistance Training (RT) |
| LGIMD+EA | Other | The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA). Receives: Behavioral: LGIMD+EA |
| LGIMD+EA/RT | Other | The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA) and resistance training (RT). Receives: Behavioral: LGIMD+EA/RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Alcoholic Fatty liver Disease (NAFLD) score
NAFLD score will be built with Fobroscan-CAP
Measured: up to 12 weeks
Secondary outcomes (2)
Lipid composition of erythrocyte membrane
Measured: 6 and 12 weeks
Sierical lipid profile
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
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 R Osella, MD, PhD, Principal investigator, IRCCS "Saverio De Bellis"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347696
- Sponsor's protocol ID
- NUTRIATT
- Status last verified
- Jul 2016
- First submitted
- 21 Jan 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: When data analysis will finish
Publications
Scavo MP, Negro R, Arre V, Depalo N, Carrieri L, Rizzi F, Mastrogiacomo R, Serino G, Notarnicola M, De Nunzio V, Lippolis T, Pesole PL, Coletta S, Armentano R, Curri ML, Giannelli G. The oleic/palmitic acid imbalance in exosomes isolated from NAFLD patients induces necroptosis of liver cells via the elongase-6/RIP-1 pathway. Cell Death Dis. 2023 Sep 26;14(9):635. doi: 10.1038/s41419-023-06161-9.
PubMed 37752143
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
- Effect of Two Programs of Physical Activity of Different Intensity, Mediterranean Diet and the Combination of Both on NAFLD and Erytrocyte Membrane Lipid Profile.
- ClinicalTrials.gov ID
- NCT02347696
- Acronym / sponsor ID
- NUTRIATT
- Conditions
- NAFLD
- Keywords
- Diet, Physical Activity, Trial, Lipidomics, Occidental Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 27 Jan 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.
This study aims to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index Mediterranean Diet and of the interaction of both, on NAFLD score and on the lipid composition of the erythrocyte membrane.
Detailed description
The surveys conducted on the populations of Castellana Grotte and Putignano (Bari, Italy) evidenced that Non-Alcoholic Fatty liver Disease (NAFLD) reaches a prevalence of 30%, especially among aged and male individuals. Being a crucial outcome of several metabolic alterations, it becomes imperative for Public Health to adopt strategies aimed to control the factors responsible for NAFLD onset.
The objective of this study is to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index Mediterranean Diet and of the interaction of both, on NAFLD score and on the lipid composition of the erythrocyte membrane.
Study participants responding to the inclusion criteria of this trial will be chosen both in the hospital setting and in the general practitioners' clinics. At the enrollement, anthropometric and biochemical variables will be measured, as well as bioimpedenziometric and calorimetric parameters; participants will also undergo Fibroscan-CAP to measure the outcome and will be asked about their medical history and life-style. Subjects will be randomized to the different arms of the trial and be followed-up at the end of the sixth and the twelfth week of enrollement.
All data will be statistically analysed by applying the Chi-Square test and t-test for discrete and continuous variables, respectively. As it deals with the analysis of data repeatedly measured on the same subject, the Generalized Estimating Equation (GEE) will be applied to evaluate the effect of the intervention on the outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Behavioral: ControlThe subjects will follow a diet based on INRAN guidelines without doing any physical activity. |
| LGIMD | Other | Behavioral: LGIMDThe subjects will follow a Low Glycemic Index Mediterranean Diet without doing any physical activity. |
| Endurance Activity (EA) | Other | Behavioral: Endurance Activity (EA)The subjects will follow a program of endurance (aerobic) activity (EA) without following a specific diet. |
| EA+Resistance Training (RT) | Other | Behavioral: EA+Resistance Training (RT)The subjects will follow a program of endurance activity (EA) and resistance training (RT) without following a specific diet. |
| LGIMD+EA | Other | Behavioral: LGIMD+EAThe subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA). |
| LGIMD+EA/RT | Other | Behavioral: LGIMD+EA/RTThe subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA) and resistance training (RT). |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI ≥ 25.0
- Moderate or severe NAFLD
- 30 < age <60
Key exclusion criteria (6 listed)
- Overt cardiovascular disease and revascularization procedures;
- Stroke;
- Clinical peripheral artery disease;
- Type-2 Diabetes Mellitus (current treatment with insulin or oral hypoglycemic drugs, fasting glucose >126 mg/dl, or casual glucose >200 mg/dl);
- Severe medical condition that may impair the person to participate in a nutritional intervention 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 |
|---|---|---|
| ControlSubjects will follow a diet based on INRAN guidelines without doing any physical activity. | Behavioural | Control |
| LGIMDSubjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity. | Behavioural | LGIMD |
| Endurance Activity (EA)Subject will follow a program of endurance activity as follows: Frequency: 3 times/week Duration: 60 minutes Intensity: * weeks 1-4: 14.2 kcal*kg-1*week-1; * weeks 5-8: 18.9 kcal*kg-1*week-1; * weeks 9-12: 23.6 kcal*kg-1*week-1. | Behavioural | Endurance Activity (EA) |
| EA+Resistance Training (RT)Subject will follow a program of endurance activity as follows: Frequency: 3 times/week Duration: 60 minutes Intensity (for Endurance activity): * weeks 1-4: 14.2 kcal*kg-1*week-1; * weeks 5-8: 18.9 kcal*kg-1*week-1; * weeks 9-12: 23.6 kcal*kg-1*week-1. Resistance activity: Muscolation: Training of the bigger muscle groups (chest, shoulders, arms, abdomen, back, glutes and legs); * Progression: increase of 1-2.5 kg*week-1 * Training of all muscle groups in the same session | Behavioural | EA+Resistance Training (RT) |
| LGIMD+EASubjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity. | Behavioural | LGIMD+EA |
| LGIMD+EA/RTSubjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training. | Behavioural | LGIMD+EA/RT |
Primary outcome
Non-Alcoholic Fatty liver Disease (NAFLD) score
Time frame: up to 12 weeks
NAFLD score will be built with Fobroscan-CAP
2 secondary outcomes
Lipid composition of erythrocyte membrane
Time frame: 6 and 12 weeks
Sierical lipid profile
Time frame: 6 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Derived from this study: PubMed 37752143Scavo MP, Negro R, Arre V, Depalo N, Carrieri L, Rizzi F, Mastrogiacomo R, Serino G, Notarnicola M, De Nunzio V, Lippolis T, Pesole PL, Coletta S, Armentano R, Curri ML, Giannelli G. The oleic/palmitic acid imbalance in exosomes isolated from NAFLD patients induces necroptosis of liver cells via the elongase-6/RIP-1 pathway. Cell Death Dis. 2023 Sep 26;14(9):635. doi: 10.1038/s41419-023-06161-9.
- Individual participant dataSharing planned: Yes. When data analysis will finish
Related trials for NAFLD
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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 R Osella, MD, PhD principal investigator
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 LGIMD, Endurance Activity (EA) and EA+Resistance Training (RT) in people with NAFLD, 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 3 inclusion and 6 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto R Osella, MD, PhD (00390804994655, arosella@irccsdebellis.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Alcoholic Fatty liver Disease (NAFLD) score (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02347696, which also lists 1 linked publication.
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.