Non Alcoholic Fatty Liver DiseaseFLIPANNCT04442620
Prevention and Reversion of NAFLD in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity
A study testing Physical activity and Mediterranean Diet (PA-MD) and High meal frequency of Mediterranean Diet (HMF-MD) in people with Non Alcoholic Fatty Liver Disease, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
This prospective randomized trial evaluates the role of customized dietary and physical activity intervention on the progression of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with obesity and presenting at least three of the main Metabolic Syndrome traits. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease
- What is being tested?
- Physical activity and Mediterranean Diet (PA-MD) and High meal frequency of Mediterranean Diet (HMF-MD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 26 Oct 2017to 1 Dec 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 40 and 60 years
- Diagnosis of NAFLD by ultrasound
- BMI ≥ 27 and < 40 kg/m2
- Meeting at least 3 of 5 criteria for the metabolic syndrome [as described in the International Diabetes Federation consensus]: (1) BMI >30kg/m² or increased waist circumference: ≥ 94 cm in males; ≥ 80 cm in females; (2) Triglycerides (TG) levels ≥ 150 mg/dL (1.7 mmol/L) or specific treatment; (3) Reduced HDL cholesterol: < 40 mg/dL (1.03 mmol/L) in males; < 50 mg/dL (1.29 mmol/L) in females or specific treatment; (4) Raised blood pressure: systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension; (5) Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes
- Written informed consent
Who cannot join
- Inability or unwillingness to give informed consent or communicate with staff study
- Documented history of prior cardiovascular disease [angina; myocardial infarction; coronary revascularization procedures; stroke (ischemic or hemorrhagic including transient ischemic attacks); symptomatic peripheral artery disease that required surgery or was diagnosed with vascular imaging techniques; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure (New York Heart Association Class III or IV); hypertrophic myocardiopathy; and history of aortic aneurism >=5.5cm in diameter or aortic aneurism surgery]
- Documented history of prior liver diseases (other than NAFLD)
- Active cancer or a history of malignancy in the last 5 years
- Low predicted probability to change food habits according to the Stages of Change Model (Nigg, 1999)
- Unwillingness or inability to adhere to the dietary and physical activity intervention over the entire period of the study
Show all 18Show fewer
- Failure to follow scheduled visits
- Weight loss (>5 kg) during 6 months prior to visit
- Previous surgical procedures for weight loss or scheduled bariatric surgery within the next 12 months
- Use of weight loss medications during 6 months prior to visit
- Previous history of bowel resection, inflammatory bowel disease
- Obesity associated with endocrine disease (except treated hypothyroidism)
- Allergy to Mediterranean diet foods or components
- Severe psychiatric disorders (schizophrenia, bipolar disorder, eating disorders, or depression with hospitalization within the last 6 months) or Beck Depression Inventory score > 30
- Severe condition with less than 24 months life expectancy
- Chronic abuse of drugs or alcohol (>21 and >14 units of alcohol a week for men and women, respectively; 1 unit = 125 mL of wine)
- Treatment with steroids
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention and Reversion of Non-Alcoholic Fatty Liver Disease in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity
This prospective randomized trial evaluates the role of customized dietary and physical activity intervention on the progression of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with obesity and presenting at least three of the main Metabolic Syndrome traits.
The project proposes a personalized nutritional intervention based on a Mediterranean customized diet which introduces plenty of antioxidant and anti-inflammatory bioactive components, coupled with physical activity promotion to prevent and reverse NAFLD among obese patients with metabolic syndrome. This will be compared with two more dietary strategies including a Mediterranean Diet intervention with seven meals a day and the conventional dietary approach proposed by the American Association for the Study of Liver Diseases (AASLD).
Read the detailed description
There is currently no licensed pharmacological treatment for reversing Non-Alcoholic Fatty Liver Disease (NAFLD), this is why nutritional and lifestyle strategies are pivotal to ameliorate risk factors and prevent disease progression. Weight loss achieved by a weight loss diet and exercise is certainly the principal treatment for the amelioration of fatty liver, nevertheless quality of diet composition could also play a crucial role. Since oxidative stress and inflammation have been cited among the mechanisms involved in NAFLD, foods containing antioxidant and anti-inflammatory bioactive components should be considered when designing a nutritionally sound diet. The Mediterranean Diet, naturally rich in antioxidants and antinflammatory foods, together with personalised physical activity could have a variety of positive health effects, including the slowing down of degenerative diseases such as liver steatosis.
The present study aims to compare and evaluate the efficacy of three interventions on the pathophysiological mechanisms that may affect changes in liver fat deposits and progression of NAFLD in patients with obesity and presenting at least three of the main Metabolic Syndrome traits.
The first intervention group receives a caloric restricted Mediterranean Diet coupled with physical activity (delivered through guided gym classes); the second group receives a caloric restricted Mediterranean Diet distributed over 7 meals and advise to walk 10.000 steps a day; the third group receives the conventional diet proposed by the American Association for the Study of Liver Diseases (AASLD) and advise to walk 10.000 steps a day.
- Conditions
- Non Alcoholic Fatty Liver Disease
- Being tested
- Physical activity and Mediterranean Diet (PA-MD), High meal frequency of Mediterranean Diet (HMF-MD), Control diet (CD)
- Keywords
- Non Alcoholic Fatty Liver Disease, Metabolic syndrome, Mediterranean Diet, Physical activity
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity and Mediterranean Diet (PA-MD)Other
Physical Activity plus caloric restricted Mediterranean diet
High meal frequency of Mediterranean Diet (HMF-MD)Other
High meal frequency of unaltered Mediterranean diet
Control diet (CD)Other
Control Diet
| Study group | Role | What they receive |
|---|---|---|
| 1st group: Physical Activity and Mediterranean Diet (PA-MD) | Experimental | A first group of participants will be advised to reduce their caloric intake by 25-30% with a macronutrients distribution of 35-40% fat, 20% proteins, and 40-45% carbohydrates. Healthy fats (a maximum of 8-10% from saturated fats, >20% from monounsaturated fats, >10% from polyunsaturated fats and <300 mg/day of cholesterol) and low glycaemic index foods rich in fibre (not less than 30-35g /day) are strongly advised, together with foods rich in antioxidants, namely fruits and vegetables. Such diet reflects the traditional Mediterranean Diet described in the PREDIMED (Primary Prevention of Cardiovascular Disease with a Mediterranean Diet)-Plus study.
As for physical activity, patients the participants will be recommended a 35 minutes interval training session three times a week. Physical activity sessions of 35 minutes will consist of 5 minutes warm-up, 20 minutes interval training, and 10 minutes breathing and stretching. Receives: Other: Physical activity and Mediterranean Diet (PA-MD) |
| 2nd group: High Meal Frequency of Mediterranean Diet (HMF-MD) | Experimental | A second group of participants will be advised to reduce their caloric intake by 25-30% with a macronutrients distribution of 30-35% fat, 25% proteins, and 40-45% carbohydrates. Healthy fats and low glycaemic index foods will be strongly advised, together with foods rich in antioxidants, namely fruits and vegetables. Participants will be advised to consume 7 meals a day, gradually reducing the caloric content at each main meal, and to walk 10.000 steps a day. Receives: Other: High meal frequency of Mediterranean Diet (HMF-MD) |
| 3rd group: Control diet (CD) | Active comparator | A third group of participants will be advised to reduce their caloric intake by 25-30% with a macronutrients distribution of 30% fat, 15% proteins, and 55% carbohydrates, and maintain an adequate fibre (25g/day) and cholesterol (<250mg/day) intake. Meal frequency will be of 3-5 meals a day. Moreover, the participants will be advised to walk 10.000 steps a day. Receives: Other: Control diet (CD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in liver steatosis
The primary outcome is to measure the change of liver steatosis (expressed as percentage of liver steatosis) after applying a different intervention to each group (PA-MD; HMF-MD; or CD) of participants with metabolic syndrome.
It will be measured (at baseline, and after 6, 12 and 24 months of intervention) by means of a 1.5-T Magnetic Resonance Imaging (MRI) (Signa Explorer 1.5T, General Electric Healthcare, Chicago, Illinois., U.S.A) by using a 12-channel phased-array coil.
Measured: At baseline, 6, 12 and 24 months
Secondary outcomes (1)
Changes in liver fibrosis
The secondary otucome is to measure the changes of liver fibrosis (expressed as percentage of liver fibrosis) after applying a different intervention to each group (PA-MD; HMF-MD; or CD) of participants with metabolic syndrome.
It will be measured (at baseline, and after 6, 12 and 24 months of intervention) by using Shear Wave Measurement (SWM) (Hitachi Ltd, Japan) and the echograph Arietta V70 (Hitachi Medical System Europe Holding AG, Steinhausen, Switzerland).
Measured: At baseline, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start26 Oct 2017
- Primary completion29 Nov 2019
- Study completion1 Dec 2021 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Responsible party
- Principal investigator, Josep1, University of the Balearic Islands
- Investigators
- Josep A Tur, PhD, Principal investigator, University of the Balearic Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442620
- Sponsor's protocol ID
- 201630.10
- Acronym
- FLIPAN
- Status last verified
- Jun 2020
- First submitted
- 28 Jan 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are restrictions on the availability of data for the FLIPAN trial, due to the signed consent agreements around data sharing, which only allow access to external researchers for studies following the project purposes. Requestors wishing to access the FLIPAN trial data used in this study can make a request to the FLIPAN trial. Steering Committee chair: pep.tur@uib.es. The request will then be passed to members of the FLIPAN Steering Committee for deliberation.
Publications
Quetglas-Llabres MM, Monserrat-Mesquida M, Bouzas C, Llompart I, Mateos D, Casares M, Ugarriza L, Martinez JA, Tur JA, Sureda A. Mediterranean Diet Improves Plasma Biomarkers Related to Oxidative Stress and Inflammatory Process in Patients with Non-Alcoholic Fatty Liver Disease. Antioxidants (Basel). 2023 Mar 29;12(4):833. doi: 10.3390/antiox12040833.
PubMed 37107208
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Reversion of Non-Alcoholic Fatty Liver Disease in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity
- ClinicalTrials.gov ID
- NCT04442620
- Acronym / sponsor ID
- FLIPAN / 201630.10
- Conditions
- Non Alcoholic Fatty Liver Disease
- Keywords
- Non Alcoholic Fatty Liver Disease, Metabolic syndrome, Mediterranean Diet, Physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 22 Jun 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.
This prospective randomized trial evaluates the role of customized dietary and physical activity intervention on the progression of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with obesity and presenting at least three of the main Metabolic Syndrome traits.
The project proposes a personalized nutritional intervention based on a Mediterranean customized diet which introduces plenty of antioxidant and anti-inflammatory bioactive components, coupled with physical activity promotion to prevent and reverse NAFLD among obese patients with metabolic syndrome. This will be compared with two more dietary strategies including a Mediterranean Diet intervention with seven meals a day and the conventional dietary approach proposed by the American Association for the Study of Liver Diseases (AASLD).
Detailed description
There is currently no licensed pharmacological treatment for reversing Non-Alcoholic Fatty Liver Disease (NAFLD), this is why nutritional and lifestyle strategies are pivotal to ameliorate risk factors and prevent disease progression. Weight loss achieved by a weight loss diet and exercise is certainly the principal treatment for the amelioration of fatty liver, nevertheless quality of diet composition could also play a crucial role. Since oxidative stress and inflammation have been cited among the mechanisms involved in NAFLD, foods containing antioxidant and anti-inflammatory bioactive components should be considered when designing a nutritionally sound diet. The Mediterranean Diet, naturally rich in antioxidants and antinflammatory foods, together with personalised physical activity could have a variety of positive health effects, including the slowing down of degenerative diseases such as liver steatosis.
The present study aims to compare and evaluate the efficacy of three interventions on the pathophysiological mechanisms that may affect changes in liver fat deposits and progression of NAFLD in patients with obesity and presenting at least three of the main Metabolic Syndrome traits.
The first intervention group receives a caloric restricted Mediterranean Diet coupled with physical activity (delivered through guided gym classes); the second group receives a caloric restricted Mediterranean Diet distributed over 7 meals and advise to walk 10.000 steps a day; the third group receives the conventional diet proposed by the American Association for the Study of Liver Diseases (AASLD) and advise to walk 10.000 steps a day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1st group: Physical Activity and Mediterranean Diet (PA-MD) | Experimental | Other: Physical activity and Mediterranean Diet (PA-MD)A first group of participants will be advised to reduce their caloric intake by 25-30% with a macronutrients distribution of 35-40% fat, 20% proteins, and 40-45% carbohydrates. Healthy fats (a maximum of 8-10% from saturated fats, >20% from monounsaturated fats, >10% from polyunsaturated fats and <300 mg/day of cholesterol) and low glycaemic index foods rich in fibre (not less than 30-35g /day) are strongly advised, together with foods rich in antioxidants, namely fruits and vegetables. Such diet reflects the traditional Mediterranean Diet described in the PREDIMED (Primary Prevention of Cardiovascular Disease with a Mediterranean Diet)-Plus study. As for physical activity, patients the participants will be recommended a 35 minutes interval training session three times a week. Physical activity sessions of 35 minutes will consist of 5 minutes warm-up, 20 minutes interval training, and 10 minutes breathing and stretching. |
| 2nd group: High Meal Frequency of Mediterranean Diet (HMF-MD) | Experimental | Other: High meal frequency of Mediterranean Diet (HMF-MD)A second group of participants will be advised to reduce their caloric intake by 25-30% with a macronutrients distribution of 30-35% fat, 25% proteins, and 40-45% carbohydrates. Healthy fats and low glycaemic index foods will be strongly advised, together with foods rich in antioxidants, namely fruits and vegetables. Participants will be advised to consume 7 meals a day, gradually reducing the caloric content at each main meal, and to walk 10.000 steps a day. |
| 3rd group: Control diet (CD) | Active comparator | Other: Control diet (CD)A third group of participants will be advised to reduce their caloric intake by 25-30% with a macronutrients distribution of 30% fat, 15% proteins, and 55% carbohydrates, and maintain an adequate fibre (25g/day) and cholesterol (<250mg/day) intake. Meal frequency will be of 3-5 meals a day. Moreover, the participants will be advised to walk 10.000 steps a day. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 40 and 60 years
- Diagnosis of NAFLD by ultrasound
- BMI ≥ 27 and < 40 kg/m2
- Meeting at least 3 of 5 criteria for the metabolic syndrome [as described in the International Diabetes Federation consensus]: (1) BMI >30kg/m² or increased waist circumference: ≥ 94 cm in males; ≥ 80 cm in females; (2) Triglycerides (TG) levels ≥ 150 mg/dL (1.7 mmol/L) or specific treatment; (3) Reduced HDL cholesterol: < 40 mg/dL (1.03 mmol/L) in males; < 50 mg/dL (1.29 mmol/L) in females or specific treatment; (4) Raised blood pressure: systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension; (5) Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes
- Written informed consent
Key exclusion criteria (18 listed)
- Inability or unwillingness to give informed consent or communicate with staff study
- Documented history of prior cardiovascular disease [angina; myocardial infarction; coronary revascularization procedures; stroke (ischemic or hemorrhagic including transient ischemic attacks); symptomatic peripheral artery disease that required surgery or was diagnosed with vascular imaging techniques; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure (New York Heart Association Class III or IV); hypertrophic myocardiopathy; and history of aortic aneurism >=5.5cm in diameter or aortic aneurism surgery]
- Documented history of prior liver diseases (other than NAFLD)
- Active cancer or a history of malignancy in the last 5 years
- Low predicted probability to change food habits according to the Stages of Change Model (Nigg, 1999)
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 |
|---|---|---|
| Physical activity and Mediterranean Diet (PA-MD)Physical Activity plus caloric restricted Mediterranean diet | Other | 1st group: Physical Activity and Mediterranean Diet (PA-MD) |
| High meal frequency of Mediterranean Diet (HMF-MD)High meal frequency of unaltered Mediterranean diet | Other | 2nd group: High Meal Frequency of Mediterranean Diet (HMF-MD) |
| Control diet (CD)Control Diet | Other | 3rd group: Control diet (CD) |
Primary outcome
Changes in liver steatosis
Time frame: At baseline, 6, 12 and 24 months
The primary outcome is to measure the change of liver steatosis (expressed as percentage of liver steatosis) after applying a different intervention to each group (PA-MD; HMF-MD; or CD) of participants with metabolic syndrome. It will be measured (at baseline, and after 6, 12 and 24 months of intervention) by means of a 1.5-T Magnetic Resonance Imaging (MRI) (Signa Explorer 1.5T, General Electric Healthcare, Chicago, Illinois., U.S.A) by using a 12-channel phased-array coil.
1 secondary outcome
Changes in liver fibrosis
Time frame: At baseline, 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Derived from this study: PubMed 37107208Quetglas-Llabres MM, Monserrat-Mesquida M, Bouzas C, Llompart I, Mateos D, Casares M, Ugarriza L, Martinez JA, Tur JA, Sureda A. Mediterranean Diet Improves Plasma Biomarkers Related to Oxidative Stress and Inflammatory Process in Patients with Non-Alcoholic Fatty Liver Disease. Antioxidants (Basel). 2023 Mar 29;12(4):833. doi: 10.3390/antiox12040833.
- Individual participant dataSharing planned: No. There are restrictions on the availability of data for the FLIPAN trial, due to the signed consent agreements around data sharing, which only allow access to external researchers for studies following the project purposes. Requestors wishing to access the FLIPAN trial data used in this study can make a request to the FLIPAN trial. Steering Committee chair: pep.tur@uib.es. The request will then be passed to members of the FLIPAN Steering Committee for deliberation.
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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.
Josep A Tur, PhD principal investigator
University of the Balearic Islands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and Mediterranean Diet (PA-MD) and High meal frequency of Mediterranean Diet (HMF-MD) in people with Non Alcoholic Fatty Liver Disease, run by University of the Balearic Islands at 1 site in Spain.
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 18 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 22 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 Spain. 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?
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?
Changes in liver steatosis (time frame: At baseline, 6, 12 and 24 months). 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 NCT04442620, 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 22 Jun 2020.