Non-Alcoholic Fatty Liver DiseasePALMEDNCT04400864
Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty Liver Disease
A study testing Dietary intervention in people with Non-Alcoholic Fatty Liver Disease, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Non- alcoholic fatty liver disease (NAFLD) is one of metabolic syndrome manifestation, and has become the leading cause for cirrhosis and the need for liver transplantation. The Mediterranean diet showed in many trials its benefit in the treatment of the metabolic syndrome and NAFLD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Dec 2019to 1 May 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- NAFLD
Who cannot join
- pregnancy
- Chronic kidney disease
- post transplant
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Amir Shlomai, MD, 03-9376753, amirsh9@clalit.org.il
Hagit Lustigman, RD, 039376034, hagitl2@clalit.org.il
About this study
Official title: Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty
Non- alcoholic fatty liver disease (NAFLD) is one of metabolic syndrome manifestation, and has become the leading cause for cirrhosis and the need for liver transplantation.
The Mediterranean diet showed in many trials its benefit in the treatment of the metabolic syndrome and NAFLD. The Paleolithic Diet includes meat, fish, fruits, vegetables, nuts and seeds and avoidance of processed food and most of carbohydrates. In some studies this diet seemed to decrease triglycerides levels and improve insulin resistance.
The aim of this study is to evaluate the influance of the paleolithic diat for the treatment of NAFLD, as shown in the Mediterranean Diet.
Read the detailed description
Recruitment of 60 patients with the diagnosis NAFLD from clinics in Rabin Medical center, aged 18-65.
Two study groups- Mediterranean Diet and Paleolithic Diet The dietitian will assign randomly for the study groups, and will assess diet adherence within 6 weeks of the trial and in its end- after 3 months.
blood test for liver enzymes, lipids, crp, mda and HbA1C, will be taken at recruitment and after 3 months.
Ultrasound and elastography will be tested at recruitment and after 3 months, to evaluate the degree of the fatty liver, by a the same doctor who is blind to the study groups.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Dietary 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.
Dietary interventionOther
dietary counseling based on the principals pf the dietary intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet | Experimental | Nutritional guidelines based on the principals of the Mediterranean Diet Receives: Other: Dietary intervention |
| Paleolithic Diet | Experimental | Nutritional guidelines based on the principals of thePaleolithic Diet Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the severity of the fatty liver measured by ultrasound and elastography.
Changes in fatty liver severity score according to ultrasound wave intensity analysis- light ; moderate ; severe.
Measured: 3 months
Secondary outcomes (2)
Changes in HbA1C
Blood tests for HbA1C are taken at the beginning and the end of the trial, and analyzed for changes.
Measured: 3 months
Changes in Triglycerides levels
Blood tests for Triglycerides are taken at the beginning and the end of the trial, and analyzed for changes.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start30 Dec 2019
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Responsible party
- Principal investigator, AMIR SHLOMAI, Rabin Medical Center
- Investigators
- Amir Shlomai, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400864
- Sponsor's protocol ID
- 0122-19-rmc
- Acronym
- PALMED
- Status last verified
- May 2020
- First submitted
- 20 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty
- ClinicalTrials.gov ID
- NCT04400864
- Acronym / sponsor ID
- PALMED / 0122-19-rmc
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 26 May 2020 (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.
Non- alcoholic fatty liver disease (NAFLD) is one of metabolic syndrome manifestation, and has become the leading cause for cirrhosis and the need for liver transplantation.
The Mediterranean diet showed in many trials its benefit in the treatment of the metabolic syndrome and NAFLD. The Paleolithic Diet includes meat, fish, fruits, vegetables, nuts and seeds and avoidance of processed food and most of carbohydrates. In some studies this diet seemed to decrease triglycerides levels and improve insulin resistance.
The aim of this study is to evaluate the influance of the paleolithic diat for the treatment of NAFLD, as shown in the Mediterranean Diet.
Detailed description
Recruitment of 60 patients with the diagnosis NAFLD from clinics in Rabin Medical center, aged 18-65.
Two study groups- Mediterranean Diet and Paleolithic Diet The dietitian will assign randomly for the study groups, and will assess diet adherence within 6 weeks of the trial and in its end- after 3 months.
blood test for liver enzymes, lipids, crp, mda and HbA1C, will be taken at recruitment and after 3 months.
Ultrasound and elastography will be tested at recruitment and after 3 months, to evaluate the degree of the fatty liver, by a the same doctor who is blind to the study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet | Experimental | Other: Dietary interventionNutritional guidelines based on the principals of the Mediterranean Diet |
| Paleolithic Diet | Experimental | Other: Dietary interventionNutritional guidelines based on the principals of thePaleolithic Diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- NAFLD
Key exclusion criteria (3 listed)
- pregnancy
- Chronic kidney disease
- post transplant
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 |
|---|---|---|
| Dietary interventiondietary counseling based on the principals pf the dietary intervention group. | Other | Mediterranean Diet, Paleolithic Diet |
Primary outcome
Changes in the severity of the fatty liver measured by ultrasound and elastography.
Time frame: 3 months
Changes in fatty liver severity score according to ultrasound wave intensity analysis- light ; moderate ; severe.
2 secondary outcomes
Changes in HbA1C
Time frame: 3 months
Changes in Triglycerides levels
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- 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.
Amir Shlomai, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Non-Alcoholic Fatty Liver Disease, run by Rabin Medical Center at 1 site in Israel.
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 3 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 4 Jun 2020. 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 Israel. 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 Amir Shlomai, MD (03-9376753, amirsh9@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the severity of the fatty liver measured by ultrasound and elastography. (time frame: 3 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 4 Jun 2020.