Liver TransplantationNCT04672863
Mediterranean Diet Post-liver Transplantation
A study testing Dietary Intervention in people with Liver Transplantation, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to study the effects of a structured Mediterranean dietary program on prevention of weight gain, promotion of heart health and prevention of fatty liver disease after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥ 18 years of age undergoing primary liver transplant
- Ascites-adjusted BMI ≥ 25 kg/m2
- Acceptable graft function (total bilirubin level < 5 mg/dL and doppler ultrasound with patent hepatic artery, hepatic veins and portal veins)
Who cannot join
- Hepatocellular carcinoma (HCC) that did not fulfill Milan criteria as per explant histology
- Untreated post-transplant vascular complications or biliary strictures
- Multi-organ transplantation
- Urine protein excretion ≥2.0 g/day
- Uncontrolled diabetes mellitus (HbA1c > 10%)
- Associated medical conditions incompatible with safe participation in a nutritional intervention study, including digestive diseases with fat intolerance, neurological, psychiatric or endocrine disorders
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- Active eating disorder (e.g. bulimia nervosa, anorexia nervosa)
- History of bariatric surgery
- Pregnancy or planning on pregnancy in the next year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Kymberly Watt, MD, 5072661586, watt.kymberly@mayo.edu
About this study
Official title: Effects of a Structured, Modified Mediterranean Dietary Intervention After Liver Transplantation
The purpose of this study is to study the effects of a structured Mediterranean dietary program on prevention of weight gain, promotion of heart health and prevention of fatty liver disease after liver transplantation.
Read the detailed description
Study Hypotheses
- A modified Mediterranean diet after liver transplantation results in weight loss, improvement of insulin sensitivity, lipid profiles, blood pressure, BMI, and waist circumference in patients who adhere to the program.
- A modified Mediterranean diet after liver transplantation results in relative improvement in cardiovascular outcomes in patients who adhere to the program when compared to standard of care.
- A modified Mediterranean diet after liver transplantation results in relative improvement in 10-year ASCVD risk in patients who adhere to the program when compared to standard of care.
- A modified Mediterranean diet after liver transplantation decreases the risk of development of NAFLD/NASH/NASH fibrosis in patients who adhere to the program.
Study Design:
- Single-center, prospective, randomized interventional trial
- All eligible post-liver transplant patients during the enrollment period will be invited to participate in the trial.
- All enrolled patients will be randomized to the Dietary Intervention (DI) arm or the Standard of Care (SOC) arm.
- All patients will be followed for 12 months.
- Conditions
- Liver Transplantation
- Being tested
- Dietary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionBehavioural
Modified Mediterranean diet approved by the Nutrition Team at the Transplant Center and it emphasizes consumption of fruits, vegetables, whole grains, beans and nuts, in addition to low salt (2-2.4g/day), moderate amounts of lean protein (primarily fish and poultry) in addition to low to moderate quantities of monounsaturated fats. The modifications to the traditional Mediterranean diet are: no alcohol consumption and fewer added fats. In addition, close scheduled followup on diet and progress with study team.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | No intervention | Subjects will participate in a standardized Transplant Nutrition class between day 21-40 as per institutional protocol and will be counseled as per the Mayo Clinic standard of care vis a vis dietary intervention, standard aerobic and resistance exercise recommendations (consistent with AASLD guidelines) and other lifestyle interventions. |
| Behavioral: Structured Modified Mediterranean Diet | Experimental | Subjects will participate in a one-on-one counselling session with a dietician, as opposed to attending the standardized Transplant Nutrition class. Counselling will be provided on the elements of the modified Mediterranean diet which emphasizes consumption of fruits, vegetables, whole grains, beans and nuts, in addition to low salt, moderate amounts of lean protein (primarily fish and poultry) in addition to low to moderate quantities of monounsaturated fats. Receives: Behavioral: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
weight in kilograms
Measured: 4 months
weight gain
weight in kilograms
Measured: 12 months
Secondary outcomes (2)
fat mass changes
InBody body composition analysis of fat mass vs lean body mass changes
Measured: 4 months
fat mass changes
InBody body composition analysis of fat mass vs lean body mass changes
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 posted17 Dec 2020
- Study start19 Jan 2021
- Primary completion1 Mar 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kymberly D. Watt, Mayo Clinic
- Investigators
- Kymberly Watt, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672863
- Sponsor's protocol ID
- 20-009762
- Status last verified
- Jan 2026
- First submitted
- 7 Dec 2020
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Structured, Modified Mediterranean Dietary Intervention After Liver Transplantation
- ClinicalTrials.gov ID
- NCT04672863
- Acronym / sponsor ID
- 20-009762
- Conditions
- Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 17 Dec 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.
The purpose of this study is to study the effects of a structured Mediterranean dietary program on prevention of weight gain, promotion of heart health and prevention of fatty liver disease after liver transplantation.
Detailed description
Study Hypotheses
- A modified Mediterranean diet after liver transplantation results in weight loss, improvement of insulin sensitivity, lipid profiles, blood pressure, BMI, and waist circumference in patients who adhere to the program.
- A modified Mediterranean diet after liver transplantation results in relative improvement in cardiovascular outcomes in patients who adhere to the program when compared to standard of care.
- A modified Mediterranean diet after liver transplantation results in relative improvement in 10-year ASCVD risk in patients who adhere to the program when compared to standard of care.
- A modified Mediterranean diet after liver transplantation decreases the risk of development of NAFLD/NASH/NASH fibrosis in patients who adhere to the program.
Study Design:
- Single-center, prospective, randomized interventional trial
- All eligible post-liver transplant patients during the enrollment period will be invited to participate in the trial.
- All enrolled patients will be randomized to the Dietary Intervention (DI) arm or the Standard of Care (SOC) arm.
- All patients will be followed for 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | No intervention | –Subjects will participate in a standardized Transplant Nutrition class between day 21-40 as per institutional protocol and will be counseled as per the Mayo Clinic standard of care vis a vis dietary intervention, standard aerobic and resistance exercise recommendations (consistent with AASLD guidelines) and other lifestyle interventions. |
| Behavioral: Structured Modified Mediterranean Diet | Experimental | Behavioral: Dietary InterventionSubjects will participate in a one-on-one counselling session with a dietician, as opposed to attending the standardized Transplant Nutrition class. Counselling will be provided on the elements of the modified Mediterranean diet which emphasizes consumption of fruits, vegetables, whole grains, beans and nuts, in addition to low salt, moderate amounts of lean protein (primarily fish and poultry) in addition to low to moderate quantities of monounsaturated fats. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients ≥ 18 years of age undergoing primary liver transplant
- Ascites-adjusted BMI ≥ 25 kg/m2
- Acceptable graft function (total bilirubin level < 5 mg/dL and doppler ultrasound with patent hepatic artery, hepatic veins and portal veins)
Key exclusion criteria (9 listed)
- Hepatocellular carcinoma (HCC) that did not fulfill Milan criteria as per explant histology
- Untreated post-transplant vascular complications or biliary strictures
- Multi-organ transplantation
- Urine protein excretion ≥2.0 g/day
- Uncontrolled diabetes mellitus (HbA1c > 10%)
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 InterventionModified Mediterranean diet approved by the Nutrition Team at the Transplant Center and it emphasizes consumption of fruits, vegetables, whole grains, beans and nuts, in addition to low salt (2-2.4g/day), moderate amounts of lean protein (primarily fish and poultry) in addition to low to moderate quantities of monounsaturated fats. The modifications to the traditional Mediterranean diet are: no alcohol consumption and fewer added fats. In addition, close scheduled followup on diet and progress with study team. | Behavioural | Behavioral: Structured Modified Mediterranean Diet |
Primary outcome
weight gain
Time frame: 4 months
weight in kilograms
weight gain
Time frame: 12 months
weight in kilograms
2 secondary outcomes
fat mass changes
Time frame: 4 months
fat mass changes
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Kymberly Watt, MD principal investigator
Mayo Clinic
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 Liver Transplantation, run by Mayo Clinic at 1 site in United States.
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 9 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Qasim Khan, M.B.B.S. (507-284-3917, khan.mohammadqasim@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight gain (time frame: 4 months). The study lists 2 primary outcomes in all. 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 7 Jan 2026.