Liver TransplantationNCT02174783
Mediterranean Diet and Protein-Sparing Modified Diet for Metabolic Syndrome in Liver Transplant Recipients
A study testing Mediterranean diet and Protein-Sparing Modified Fast (PSMF) in people with Liver Transplantation and Metabolic Syndrome X, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Many metabolic complications can develop after liver transplant including: diabetes, high blood pressure, obesity, heart attacks and stroke. The goal of this study is to look at the safety and effect of 2 well known and established diet regimens on the people who had a prior liver transplant and investigate whether it… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Metabolic Syndrome X, Obesity
- What is being tested?
- Mediterranean diet and Protein-Sparing Modified Fast (PSMF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Apr 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients > 18 years old who had a successful liver transplant at least 1 year prior to enrollment who also have a BMI>30 with previous failed attempts at weight loss via conventional methods. In addition to one of the following:
- Triglyceride (TG)>150 mg/dl or specific treatment for this lipid abnormality
- HDL <40 mg/dl in females and <50 mg/dl in males or specific treatment of this lipid abnormality
- Systolic BP >130 or diastolic BP >85 mm Hg or treatment for previously diagnosed hypertension
- Fasting plasma glucose >100 mg/dl or previously diagnosed type 12 diabetes
Who cannot join
- Significant behavioral issues that would interfere with compliance
- Lack of readiness to change (pre-contemplation, contemplation or preparation stages)
- Previous bariatric surgery
- Pregnant or planning to become pregnant
- History of a documented eating disorder (e.g. bulimia)
- History of kidney stones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of Mediterranean Diet and Protein-Sparing Modified Diet on Obesity and Metabolic Syndrome in Liver Transplant Recipients: A Randomized Clinical Trial
Many metabolic complications can develop after liver transplant including: diabetes, high blood pressure, obesity, heart attacks and stroke. The goal of this study is to look at the safety and effect of 2 well known and established diet regimens on the people who had a prior liver transplant and investigate whether it helps with the control of these comorbidities.
Read the detailed description
The Mediterranean diet has been shown to be effective in improving hepatic steatosis, insulin sensitivity, diabetes control and reducing cardiovascular risk in adult patients, but there is no data available for patients who underwent liver transplant. The protein-sparing modified fast (PSMF) diet has been used for years at the Cleveland Clinic to treat adult patients with obesity-related medical problems, but its safety and efficacy has not been established in liver transplant recipients.
- Conditions
- Liver Transplantation, Metabolic Syndrome X, Obesity
- Being tested
- Control group, Mediterranean diet, Protein-Sparing Modified Fast (PSMF)
- Keywords
- Weight Loss, Diet, Mediterranean, Diet, Reducing, protein sparing modified diet
- Medical subject headings
- Metabolic Syndrome, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
Patient will be provided with basic nutrition educational materials that outline principles of a healthy diet, including: moderation, portion control, increased intakes of fruits, vegetables and whole grains and reduced intakes of saturated fat, salt and sugar. Brief education will be provided by the hepatologist without dietitian referral.
Mediterranean dietOther
Patient will receive verbal diet instruction from the dietitian or from the hepatologist who has received instruction from the dietitian on following the Mediterranean diet.
Protein-Sparing Modified Fast (PSMF)Other
Patient will be referred to the dietitian for an appointment to discuss the PSMF plan.
Protein needs of 1.5 grams/kilogram will be calculated based on patient's actual body weight.
Patient will receive verbal instruction from the dietitian, as well as printed materials for reference at home. Dietitian will provide a list of allowed and prohibited foods as per Cleveland Clinic's PSMF diet standards.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Standard of care group Receives: Other: Control group |
| Mediterranean diet | Experimental | Mediterranean diet for 6 months Receives: Other: Mediterranean diet |
| Protein-Sparing Modified Fast (PSMF) | Experimental | PSMF for 6 months Receives: Other: Protein-Sparing Modified Fast (PSMF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 6 months
Secondary outcomes (5)
Number of Participants with Serious and Non-Serious Adverse Events
Investigate the safety of the mediterranean diet and PSMF in post liver transplant patients
Measured: 6 months
Change in Hb A1c compared to baseline
Measured: 6 months
Change in HDL and LDL compared to baseline
Measured: 6 months
Change in triglyceride compared to baseline
Measured: 6 months
Change in blood pressure compared to baseline
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 posted26 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionApr 2015
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 The Cleveland 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mohammed Eyad Yaseen Alsabbagh, MD, Principal investigator, The Cleveland ClinicNaim Alkhouri, MD, Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174783
- Sponsor's protocol ID
- PTMS-9500
- Status last verified
- Jul 2014
- First submitted
- 23 Jun 2014
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Mediterranean Diet and Protein-Sparing Modified Diet on Obesity and Metabolic Syndrome in Liver Transplant Recipients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02174783
- Acronym / sponsor ID
- PTMS-9500
- Conditions
- Liver Transplantation, Metabolic Syndrome X, Obesity
- Keywords
- Weight Loss, Diet, Mediterranean, Diet, Reducing, protein sparing modified diet
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Jun 2014 (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.
Many metabolic complications can develop after liver transplant including: diabetes, high blood pressure, obesity, heart attacks and stroke. The goal of this study is to look at the safety and effect of 2 well known and established diet regimens on the people who had a prior liver transplant and investigate whether it helps with the control of these comorbidities.
Detailed description
The Mediterranean diet has been shown to be effective in improving hepatic steatosis, insulin sensitivity, diabetes control and reducing cardiovascular risk in adult patients, but there is no data available for patients who underwent liver transplant. The protein-sparing modified fast (PSMF) diet has been used for years at the Cleveland Clinic to treat adult patients with obesity-related medical problems, but its safety and efficacy has not been established in liver transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Control groupStandard of care group |
| Mediterranean diet | Experimental | Other: Mediterranean dietMediterranean diet for 6 months |
| Protein-Sparing Modified Fast (PSMF) | Experimental | Other: Protein-Sparing Modified Fast (PSMF)PSMF for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients > 18 years old who had a successful liver transplant at least 1 year prior to enrollment who also have a BMI>30 with previous failed attempts at weight loss via conventional methods. In addition to one of the following:
- Triglyceride (TG)>150 mg/dl or specific treatment for this lipid abnormality
- HDL <40 mg/dl in females and <50 mg/dl in males or specific treatment of this lipid abnormality
- Systolic BP >130 or diastolic BP >85 mm Hg or treatment for previously diagnosed hypertension
- Fasting plasma glucose >100 mg/dl or previously diagnosed type 12 diabetes
Key exclusion criteria (6 listed)
- Significant behavioral issues that would interfere with compliance
- Lack of readiness to change (pre-contemplation, contemplation or preparation stages)
- Previous bariatric surgery
- Pregnant or planning to become pregnant
- History of a documented eating disorder (e.g. bulimia)
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 |
|---|---|---|
| Control groupPatient will be provided with basic nutrition educational materials that outline principles of a healthy diet, including: moderation, portion control, increased intakes of fruits, vegetables and whole grains and reduced intakes of saturated fat, salt and sugar. Brief education will be provided by the hepatologist without dietitian referral. | Other | Control group |
| Mediterranean dietPatient will receive verbal diet instruction from the dietitian or from the hepatologist who has received instruction from the dietitian on following the Mediterranean diet. | Other | Mediterranean diet |
| Protein-Sparing Modified Fast (PSMF)Patient will be referred to the dietitian for an appointment to discuss the PSMF plan. Protein needs of 1.5 grams/kilogram will be calculated based on patient's actual body weight. Patient will receive verbal instruction from the dietitian, as well as printed materials for reference at home. Dietitian will provide a list of allowed and prohibited foods as per Cleveland Clinic's PSMF diet standards. | Other | Protein-Sparing Modified Fast (PSMF) |
Primary outcome
Weight loss
Time frame: 6 months
5 secondary outcomes
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: 6 months
Change in Hb A1c compared to baseline
Time frame: 6 months
Change in HDL and LDL compared to baseline
Time frame: 6 months
Change in triglyceride compared to baseline
Time frame: 6 months
Change in blood pressure compared to baseline
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
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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.
mohammed Eyad Yaseen Alsabbagh, MD principal investigator
The Cleveland Clinic
Naim Alkhouri, MD study director
The Cleveland 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 Mediterranean diet and Protein-Sparing Modified Fast (PSMF) in people with Liver Transplantation and Metabolic Syndrome X, run by The Cleveland 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 5 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: stopped early, as of the sponsor's last update on 14 Mar 2017. 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?
The study was stopped early. Results are not available in the source record.
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: 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 14 Mar 2017.