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Chrononutrition/ Chronotoxicity Intervention in People With Metabolic-associated Steatotic Liver Disease.

NCT06705868 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

  • MASLD
  • MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
  • NAFLD
  • NAFLD - Non-Alcoholic Fatty Liver Disease
  • NAFLD (Nonalcoholic Fatty Liver Disease)

Interventions

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

OTHER

Lifestyle Management

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.

Sponsors & Collaborators

  • Cyprus State Heath Organization Services

    collaborator UNKNOWN

  • Cyprus University of Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2027-12-15
Completion
2029-12-15

Countries

  • Cyprus

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06705868 on ClinicalTrials.gov