Dietary IntakeNCT02649049
Dietary Determinants in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
An observational study of Dietary Intake and NAFLD, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial summary
Patients with NAFLD and matched controls will be asked about their demographic status, and their previous year dietary intakes using a validated FFQ. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Intake, NAFLD
- How many people
- 1,200 participants
- Where
- 1 siteIran
- Study dates
- Jan 2015to Mar 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with NAFLD diagnosed using Fibroscan without any other chronic disorders.
Who may be able to join
- age more than 18
- NAFLD was diagnosed by Fibroscan and other hepatic disorders ruled out
Who cannot join
- not completing more than 10% of the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Dietary Intakes of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
Patients with NAFLD and matched controls will be asked about their demographic status, and their previous year dietary intakes using a validated FFQ.
- Conditions
- Dietary Intake, NAFLD
- Being tested
- there is no intervention
- 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.
there is no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with NAFLD | Patients with NAFLD are the cases. Receives: Other: there is no intervention | |
| control group | Healthy people without NAFLD are controls. Receives: Other: there is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
nonalcoholic fatty liver disease diagnosed by Fibroscan
patients with confirmed diagnosis will be asked about their dietary intakes
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 posted7 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary IntakeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649049
- Sponsor's protocol ID
- 565
- Status last verified
- Sep 2016
- First submitted
- 3 Jan 2016
- Last updated
- 22 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dietary Intakes of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT02649049
- Acronym / sponsor ID
- 565
- Conditions
- Dietary Intake, NAFLD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Jan 2016 (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.
Patients with NAFLD and matched controls will be asked about their demographic status, and their previous year dietary intakes using a validated FFQ.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with NAFLD | – | Other: there is no interventionPatients with NAFLD are the cases. |
| control group | – | Other: there is no interventionHealthy people without NAFLD are controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with NAFLD diagnosed using Fibroscan without any other chronic disorders.
Key inclusion criteria (2 listed)
- age more than 18
- NAFLD was diagnosed by Fibroscan and other hepatic disorders ruled out
Key exclusion criteria (1 listed)
- not completing more than 10% of the questionnaire
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 |
|---|---|---|
| there is no intervention | Other | Patients with NAFLD, control group |
Primary outcome
nonalcoholic fatty liver disease diagnosed by Fibroscan
Time frame: 6 months
patients with confirmed diagnosis will be asked about their dietary intakes
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 22 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Intake and NAFLD, run by National Nutrition and Food Technology Institute at 1 site in Iran.
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 2 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 22 Sep 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 Iran. 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?
nonalcoholic fatty liver disease diagnosed by Fibroscan (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 22 Sep 2016.