Non Alcoholic Fatty Liver DiseaseSEELNNCT03300661
Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine
A study testing Mediterranean Style in people with Non Alcoholic Fatty Liver Disease and Lifestyle, run by Università degli Studi di Brescia at 1 site in Italy.
Trial summary
The study is an open-label intervention non pharmacological Cohort Study without control arm in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects. The intervention in patients with NAFLD is educational, providing personalized suggestions to improve diet and physical activity; the… Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease, Lifestyle, Diet Modification
- What is being tested?
- Mediterranean Style
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jun 2017to 20 May 2019
- 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 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of Fatty Liver at ultrasonography
Who cannot join
- Pregnancy;
- Breast Feeding
- Cirrhosis or End Stage Liver Disease
- Fatty Liver due to Hepatic Diseases other than Non Alcoholic Fatty Liver disease
- Concomitant severe clinical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Non-Pharmacological, Intervention Cohort Study Without Control Arm, in Patients With Non Alcoholic Fatty Liver Disease and in Healthy Subjects.
The study is an open-label intervention non pharmacological Cohort Study without control arm in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects.
The intervention in patients with NAFLD is educational, providing personalized suggestions to improve diet and physical activity; the intervention in healthy subjects is educational, providing general suggestions to improve diet and physical activity.
- Being tested
- Mediterranean Style
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean StyleBehavioural
After completion of a Food Frequency Questinnaire (FFQ) and the International Physical Activity Questionnaire (IPAQ), patients enrolled in the study undergo a personalized educational intervention by a registered dietician. During the intervention the dietician advice about the main errors in diet and physical activity (by FFQ and IPAQ) and chooses three aims in diet modification and one aim in physical activity improvement. Patients adherence is assessed by the same dietician every three months, using FFQ and IPAQ, and futher supports are provided. Total intervention lenght is twelve months.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Style | Experimental | Educational intervention with personalized suggestions to improve diet and physical activity Receives: Behavioral: Mediterranean Style |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
A reduction of at least 3 Kg
Measured: 12 months
Body Mass Index (BMI) decrease
A dicresae of at least 1Kg/m2
Measured: 12 months
Waist Circumference (WC) decrease
A decrease of at least 1.5 cm
Measured: 12 months
Secondary outcomes (3)
Blood sugar level decrease
A decrease of 6 mg/dL
Measured: 12 months
Blood cholesterol level decrease
A decrease of 9 mg/dL
Measured: 12 months
Blood triglycerides level dicrease
A decrease of 12 mg/dL
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start13 Jun 2017
- Primary completion17 May 2019
- Study completion20 May 2019
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 Non Alcoholic Fatty Liver DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single cohort of patients with NAFLD, without control group.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Ricci, Università degli Studi di Brescia
- Investigators
- Chiara Ricci, MD. PhD, Principal investigator, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300661
- Sponsor's protocol ID
- Ubrescia
- Acronym
- SEELN
- Status last verified
- May 2019
- First submitted
- 28 Sep 2017
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zanini B, Benini F, Marullo M, Simonetto A, Rossi A, Cavagnoli P, Bonalumi A, Marconi S, Pigozzi MG, Gilioli G, Valerio A, Donato F, Castellano M, Ricci C. Mediterranean-Oriented Dietary Intervention Is Effective to Reduce Liver Steatosis in Patients with Nonalcoholic Fatty Liver Disease: Results from an Italian Clinical Trial. Int J Clin Pract. 2024 Jan 25;2024:8861126. doi: 10.1155/2024/8861126. eCollection 2024.
PubMed 38303926
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Non-Pharmacological, Intervention Cohort Study Without Control Arm, in Patients With Non Alcoholic Fatty Liver Disease and in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03300661
- Acronym / sponsor ID
- SEELN / Ubrescia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 3 Oct 2017 (actual)
- 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.
The study is an open-label intervention non pharmacological Cohort Study without control arm in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects.
The intervention in patients with NAFLD is educational, providing personalized suggestions to improve diet and physical activity; the intervention in healthy subjects is educational, providing general suggestions to improve diet and physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single cohort of patients with NAFLD, without control group.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Style | Experimental | Behavioral: Mediterranean StyleEducational intervention with personalized suggestions to improve diet and physical activity |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Presence of Fatty Liver at ultrasonography
Key exclusion criteria (5 listed)
- Pregnancy;
- Breast Feeding
- Cirrhosis or End Stage Liver Disease
- Fatty Liver due to Hepatic Diseases other than Non Alcoholic Fatty Liver disease
- Concomitant severe clinical condition
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 StyleAfter completion of a Food Frequency Questinnaire (FFQ) and the International Physical Activity Questionnaire (IPAQ), patients enrolled in the study undergo a personalized educational intervention by a registered dietician. During the intervention the dietician advice about the main errors in diet and physical activity (by FFQ and IPAQ) and chooses three aims in diet modification and one aim in physical activity improvement. Patients adherence is assessed by the same dietician every three months, using FFQ and IPAQ, and futher supports are provided. Total intervention lenght is twelve months. | Behavioural | Mediterranean Style |
Primary outcome
Weight loss
Time frame: 12 months
A reduction of at least 3 Kg
Body Mass Index (BMI) decrease
Time frame: 12 months
A dicresae of at least 1Kg/m2
Waist Circumference (WC) decrease
Time frame: 12 months
A decrease of at least 1.5 cm
3 secondary outcomes
Blood sugar level decrease
Time frame: 12 months
Blood cholesterol level decrease
Time frame: 12 months
Blood triglycerides level dicrease
Time frame: 12 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 23 May 2019.
- Derived from this study: PubMed 38303926Zanini B, Benini F, Marullo M, Simonetto A, Rossi A, Cavagnoli P, Bonalumi A, Marconi S, Pigozzi MG, Gilioli G, Valerio A, Donato F, Castellano M, Ricci C. Mediterranean-Oriented Dietary Intervention Is Effective to Reduce Liver Steatosis in Patients with Nonalcoholic Fatty Liver Disease: Results from an Italian Clinical Trial. Int J Clin Pract. 2024 Jan 25;2024:8861126. doi: 10.1155/2024/8861126. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Chiara Ricci, MD. PhD principal investigator
Università degli Studi di Brescia
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 Style in people with Non Alcoholic Fatty Liver Disease and Lifestyle, run by Università degli Studi di Brescia 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 5 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 23 May 2019. 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?
Weight loss (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT03300661, 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 23 May 2019.