Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
Study NCT ID:
NCT06705868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2024-11-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chrononutrition/ Chronotoxicity Intervention in People With Metabolic-associated Steatotic Liver Disease.
Sponsor:
Cyprus University of Technology
Organization:
Study Overview
Official Title:
Time-restricted Eating in Patients With Metabolic-associated Steatotic Liver Disease . CHRONOMASLD: A Chrononutrition/Chronotoxicity Randomized Controlled Trial.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHRONOMASLD
Brief Summary:
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:
1. Does compliance in a TRE dietary scheme (positively) affect changes in body weight and body fat mass in people diagnosed with MASLD?
2. Does an additional time restriction on the consumption of fruits and vegetables within the "light-window" of the day affects the metabolism of food contaminants?
Participants will be asked to:
1. Adhere to a TRE dietary pattern for 3 months. TRE consists of an 8-hour eating vs 16 hours fasting within the day. First meal of the day should not occur at least an hour after wake-up time and last meal of the day should occur not later than 2 hours before bed-time.
2. Adhere to a further time restricted consumption of a "5-a-day" portions of fruits and vegetables between the "light-window hours" between 9am to 4pm.
3. Visit the Nutrition \& Dietetics Clinic once every month for anthropometric measurements (on 4 time points).
4. Collect and deliver first morning urine samples (on 7 time points).
5. Collect and deliver saliva samples at baseline and at the end of the trial (Saliva collection should occur every 4-hours for 48-hours including fasting collection at baseline and at the end of three months)
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.
The protocol of the study is an intention to treat protocol. The main research questions are:
1. Does compliance in a TRE dietary scheme (positively) affect changes in body weight and body fat mass in people diagnosed with MASLD?
2. Does an additional time restriction on the consumption of fruits and vegetables within the "light-window" of the day affects the metabolism of food contaminants?
Participants will be asked to:
1. Adhere to a TRE dietary pattern for 3 months. TRE consists of an 8-hour eating vs 16 hours fasting within the day. First meal of the day should not occur at least an hour after wake-up time and last meal of the day should occur not later than 2 hours before bed-time.
2. Adhere to a further time restricted consumption of a "5-a-day" portions of fruits and vegetables between the "light-window hours" between 9am to 4pm.
3. Visit the Nutrition \& Dietetics Clinic once every month for anthropometric measurements (on 4 time points).
4. Collect and deliver first morning urine samples (on 7 time points).
5. Collect and deliver saliva samples at baseline and at the end of the trial (Saliva collection should occur every 4-hours for 48-hours including fasting collection at baseline and at the end of three months)
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: