An interventional study of Diet-Time-restricted eating (TRE) and Lifestyle Management in MASLD, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and NAFLD, sponsored by Cyprus University of Technology. Not yet recruiting at 1 site in Cyprus. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Cyprus University of Technology · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to study the effect of a time-restricted eating (TRE) dietary pattern combined with a time of consumption restriction about the daily portions of fruits and vegetables in people diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD).
The protocol of the study is an intention to treat protocol. The main research questions are:
Participants will be asked to:
5) Complete a compliance and lifestyle questionnaire questionnaire via telephone interview to the research team every 2 weeks.
6) Share photos to the research team with the use of an application on time of actual fruit and vegetables consumption, 3-4 times per week throughout the study protocol.
Researchers will compare the designed intervention package of this TRE with the Standard of Care (SoC) protocol (based on the international guidelines) that is currently used in daily practice for the management of MASLD.
This parallel-arm, randomized controlled trial (RCT) will study the effects of an ad libitum TRE dietary pattern (8 hours eating, 16 hours fasting) with an additional restriction regarding the fruit and vegetable consumption on health parameters, pesticide metabolism and concomitant toxicity in MASLD patients compared with the Standard of Care (SoC) approach, that will serve as the control group. Participants will be asked to consume all meals/snacks during the 8 hours daily period that they will select for themselves without any further dietary advice regarding caloric or other macronutrient intake. However, participants will be instructed that their first meal of the day should not start for at least an hour after wake-up hour and will also be asked to have their last meal at least 2 hours earlier than bedtime (actual time of sleep). Additionally, participants will have to consume 5 portions (400g) of fruits and vegetables within time-window for fruit \& vegetable consumption earlier in the day; from 9am to 4pm.
Non-caloric beverage consumption (water, black coffee, unsweetened tea, non-sweetened beverages) will be allowed within the restricted hours of the intervention.
Participants allocated in the SoC group (control) will receive oral and written SoC lifestyle advice from a registered dietitian. The SoC advice is based on the EASL/EASD/EASO joint Clinical Practice Guidelines for the management of MASLD. Patients will receive guidance on a) energy restriction, b) weight reduction, c) the macronutrient composition of the diet, d) limitation of alcohol intake (below the risk threshold of 30g/d and 20g/day for men and women, respectively) and e) increase their physical activity levels. Additionally, in this study patients will be asked to consume standard "5-a-day" portions of fruits and vegetables daily, as part of their dietary healthier behaviour.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Cyprus University of Technology is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in Group A will follow a Standard of Care Intervention. They will receive guidance on a) energy restriction, b) weight reduction, c) the macronutrient composition of the diet, d) limitation of alcohol intake (below the risk threshold of 30g/d and 20g/day for men and women, respectively) and e) increase their physical activity levels. Additionally, in this study patients will be asked to consume the general recommendation of "5-a-day" as part of their dietary healthier behaviour. Moreover, participants should stay well hydrated and get adequate of sleep (an average of 6 consecutive hours at night). Oral and written guidance for the management of MASLD will be administered. The duration of the intervention is 3 months.
Other: Lifestyle Management
Participants will have to adhere to an ad libitum TRE dietary pattern (8 hours eating, 16 hours fasting) with an additional dietary restriction regarding the "5-a-day" fruit and vegetable in which they will need to be consumed between 9am-4pm. Some more restrictions regarding first and last meal will be asked. Participants will be instructed that their first meal of the day should not start for at least an hour after wake-up hour and will also be asked to have their last meal at least 2 hours earlier than bedtime (actual time of sleep). The duration of the intervention is 3 months.
Other: Diet-Time-restricted eating (TRE)
Ad libitum time-restricted scheme with a further time-restriction on fruit and vegetable consumption in participants with MASLD
The SoC intervention refers to an adaptation of a healthier lifestyle in elements that have to do with weight management, adopting healthier dietary habits, alcohol intake reduction, increase physical activity levels, in people diagnosed with MASLD.
Changes in body weight
Changes in body weight (in kilograms) from baseline to the end of intervention in the TRE and the Soc group (intervention vs control, respectively). Depending on the data distribution, independent samples t-test or Wilcoxon Rank-Sum Test will be used If the changes do or do not follow a normal distribution between baseline and post-treatment are normally distributed, respectively. Mixed Effect Models will be used to assess the main and interaction (included if p\<0.05) effects between groups and time since study initiation adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From enrolment to the end of treatment at 3 months (with two in-between measurement)
Changes in body fat mass
Changes in body fat mass (expressed as % of the total body weight in kilograms) from baseline to the end of intervention in the TRE and the Soc group (intervention vs control, respectively). Depending on the data distribution, independent samples t-test or Wilcoxon Rank-Sum Test will be used If the changes do or do not follow a normal distribution between baseline and post-treatment are normally distributed, respectively. Mixed Effect Models will be used to assess the main and interaction (included only if p\<0.05) effects between groups and time since study initiation adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From enrolment to the end of treatment at 3 months (with one in-between measurement)
Changes in Pesticide Metabolite 3-phenoxybenzoic Acid (3-PBA) Levels in Urine
Change in Pesticide Metabolite 3-phenoxybenzoic Acid (3-PBA) Levels in Urine (in µg/L, corrected for creatinine levels) between the TRE and the SoC intervention. Percent change in pesticide metabolite 3-phenoxybenzoic acid (3-PBA) levels between the last sample of the TRE group (intervention period) and the last sample of the SoC treatment period. The results of the linear-mixed effect models are the ones considered as they take into account the repeated measures for each participant and the TRE treatment duration adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From first day of the intervention to the end of treatment at 3 months (with six in between measurements)
Changes in Pesticide Metabolite 6-chloronicotininc Acid (6-CN) Levels in Urine
Change in Pesticide Metabolite 6-chloronicotininc Acid (6-CN) Levels in Urine (in µg/L, corrected for creatinine levels) between the TRE and the SoC intervention. Percent change in pesticide metabolite 6-chloronicotininc Acid (6-CN) levels between the last sample of the TRE group (intervention period) and the last sample of the SoC treatment period. The results of the linear-mixed effect models are the ones considered as they take into account the repeated measures for each participant and the TRE treatment duration adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From first day of the intervention to the end of treatment at 3 months (with six in between measurements)
Changes in waist circumference (WC)
Changes in waist circumference (in centimetres) from baseline to the end of intervention in the TRE and the Soc group (intervention vs control, respectively). Depending on the data distribution, independent samples t-test or Wilcoxon Rank-Sum Test will be used If the changes do or do not follow a normal distribution between baseline and post-treatment are normally distributed, respectively. Mixed Effect Models will be used to assess the main and interaction (included if p\<0.05) effects between groups and time since study initiation adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From enrolment to the end of treatment at 3 months (with one in-between measurement)
Changes in 4-Hydroxynonenal (4HNE) Levels in Urine
Change in Urine levels of the biomarker of oxidative stress 4-Hydroxynonenal (4HNE) (in µg/L, corrected for creatinine levels), between the TRE and the SoC intervention. Percent change in metabolite of oxidative stress of 4-Hydroxynonenal (4HNE) levels between the last sample of the TRE group (intervention period) and the last sample of the SoC treatment period. The results of the linear-mixed effect models are the ones considered as they take into account the repeated measures for each participant and the TRE treatment duration adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From first day of the intervention to the end of treatment at 3 months (with six in between measurements)
Changes in Body Mass Index (BMI)
Changes in Body Mass Index (in kilograms divided by meters in square) from baseline to the end of intervention in the TRE and the Soc group (intervention vs control, respectively). Depending on the data distribution, independent samples t-test or Wilcoxon Rank-Sum Test will be used If the changes do or do not follow a normal distribution between baseline and post-treatment are normally distributed, respectively. Mixed Effect Models will be used to assess the main and interaction (included if p\<0.05) effects between groups and time since study initiation adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From enrolment to the end of treatment at 3 months (with two in-between measurement)
Changes in glucose (Gluc) levels in blood
Changes on blood's glucose (Gluc) levels (in mg/dL) from baseline to the end of intervention in the TRE and the Soc group (intervention vs control, respectively). Depending on the data distribution, independent samples t-test or Wilcoxon Rank-Sum Test will be used If the changes do or do not follow a normal distribution between baseline and post-treatment are normally distributed, respectively. Mixed Effect Models will be used to assess the main and interaction (included if p\<0.05) effects between groups and time since study initiation adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From enrolment to the end of treatment at 3 months (one measurement at the beginning and one measurement at the end of the intervention)
Changes in total cholesterol (TC) levels in blood
Changes on blood's total cholesterol (TC) levels (in mg/dL) from baseline to the end of intervention in the TRE and the Soc group (intervention vs control, respectively). Depending on the data distribution, independent samples t-test or Wilcoxon Rank-Sum Test will be used If the changes do or do not follow a normal distribution between baseline and post-treatment are normally distributed, respectively. Mixed Effect Models will be used to assess the main and interaction (included if p\<0.05) effects between groups and time since study initiation adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From enrolment to the end of treatment at 3 months (one measurement at the beginning and one measurement at the end of the intervention)
Changes in high-density lipoprotein cholesterol (HDL) levels in blood
Changes on blood's high-density lipoprotein cholesterol (HDL) levels (in mg/dL) from baseline to the end of intervention in the TRE and the Soc group (intervention vs control, respectively). Depending on the data distribution, independent samples t-test or Wilcoxon Rank-Sum Test will be used If the changes do or do not follow a normal distribution between baseline and post-treatment are normally distributed, respectively. Mixed Effect Models will be used to assess the main and interaction (included if p\<0.05) effects between groups and time since study initiation adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From enrolment to the end of treatment at 3 months (one measurement at the beginning and one measurement at the end of the intervention)
Changes in low-density lipoprotein cholesterol (LDL) levels n blood
Changes on blood's low-density lipoprotein cholesterol (LDL) levels (in mg/dL) from baseline to the end of intervention in the TRE and the Soc group (intervention vs control, respectively). Depending on the data distribution, independent samples t-test or Wilcoxon Rank-Sum Test will be used If the changes do or do not follow a normal distribution between baseline and post-treatment are normally distributed, respectively. Mixed Effect Models will be used to assess the main and interaction (included if p\<0.05) effects between groups and time since study initiation adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From enrolment to the end of treatment at 3 months (one measurement at the beginning and one measurement at the end of the intervention)
Changes in alanine transaminase (ALT) levels n blood
Changes on blood's alanine transaminase (ALT) levels (in U/IL) from baseline to the end of intervention in the TRE and the Soc group (intervention vs control, respectively). Depending on the data distribution, independent samples t-test or Wilcoxon Rank-Sum Test will be used If the changes do or do not follow a normal distribution between baseline and post-treatment are normally distributed, respectively. Mixed Effect Models will be used to assess the main and interaction (included if p\<0.05) effects between groups and time since study initiation adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From enrolment to the end of treatment at 3 months (one measurement at the beginning and one measurement at the end of the intervention)
Changes in aspartate aminotransferase (AST) levels in blood
Changes on blood's aspartate aminotransferase (AST) levels (in U/IL) from baseline to the end of intervention in the TRE and the Soc group (intervention vs control, respectively). Depending on the data distribution, independent samples t-test or Wilcoxon Rank-Sum Test will be used If the changes do or do not follow a normal distribution between baseline and post-treatment are normally distributed, respectively. Mixed Effect Models will be used to assess the main and interaction (included if p\<0.05) effects between groups and time since study initiation adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From enrolment to the end of treatment at 3 months (one measurement at the beginning and one measurement at the end of the intervention)
Changes in C-Reactive Protein (CRP) levels n blood
Changes on blood's C-Reactive Protein (CRP) levels (in mg/dL) from baseline to the end of intervention in the TRE and the Soc group (intervention vs control, respectively). Depending on the data distribution, independent samples t-test or Wilcoxon Rank-Sum Test will be used If the changes do or do not follow a normal distribution between baseline and post-treatment are normally distributed, respectively. Mixed Effect Models will be used to assess the main and interaction (included if p\<0.05) effects between groups and time since study initiation adjusting for confounders, including circadian rhythm metrics such as melatonin and/or cortisol.
Time frame: From enrolment to the end of treatment at 3 months (one measurement at the beginning and one measurement at the end of the intervention)
Changes in other pesticide biomarkers in urine
Change in Change in other pesticide biomarkers in Urine (in µg/L, corrected for creatinine levels) between the TRE and the SoC intervention. Percent change in any other measured pesticide metabolite between the last sample of the TRE group (intervention period) and the last sample of the SoC treatment period. The results of the linear-mixed effect models are the ones considered as they take into account the repeated measures for each participant and the TRE treatment duration. Levels in Urine (in µg/L, corrected for creatinine levels) between the TRE and the SoC intervention. Percent change in other pesticide biomarker levels between the last sample of the TRE group (intervention period) and the last sample of the SoC treatment period. The results of the linear-mixed effect models are the ones considered as they take into account the repeated measures for each participant and the TRE treatment duration, adjusting for confounders, including circadian rhythm metrics.
Time frame: From first day o the intervention to the end of treatment at 3 months (with six in between measurements)
Changes in other biomarkers of oxidative stress in urine
Change in other biomarkers of oxidative stress in Urine (in µg/L, corrected for creatinine levels) between the TRE and the SoC intervention. Percent change in any other measured biomarkers of oxidative stress between the last sample of the TRE group (intervention period) and the last sample of the SoC treatment period. The results of the linear-mixed effect models are the ones considered as they take into account the repeated measures for each participant and the TRE treatment duration. Levels in Urine (in µg/L, corrected for creatinine levels) between the TRE and the SoC intervention. Percent change in other pesticide biomarker levels between the last sample of the TRE group (intervention period) and the last sample of the SoC treatment period. The results of the linear-mixed effect models are the ones considered as they take into account the repeated measures for each participant and the TRE treatment duration adjusting for confounders, including circadian rhythm metrics.
Time frame: From first day o the intervention to the end of treatment at 3 months (with six in between measurements)
Changes in metabolome in saliva and urine
Change in metabolome profile in the 24-h in saliva or urine (in µg/L, corrected for creatinine levels) between the TRE and the SoC intervention. Percent change in metabolome profile between the last day samples of the TRE group (intervention period) and the last day samples of the SoC treatment period will be compared with an Exposome wide association analysis.
Time frame: From first day o the intervention to the end of treatment at 3 months (with six in between measurements)
Plan to share: Undecided
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Start is estimated for Jan 2026; primary completion for Dec 2027, 23 months later.
Of 357 non-industry interventional studies with no phase under Non-alcoholic Fatty Liver Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's planned 23 months is below that.
Counting every sponsor, half of 385 studies reached it within 26 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Cyprus University of Technology