Trial Outcomes & Findings for Intermittent Fasting and Metabolic Dysfunction Associated Fatty Liver Disease (NCT NCT06664684)
NCT ID: NCT06664684
Last Updated: 2025-06-26
Results Overview
The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. Hepatic steatosis was defined using controlled attenuation parameter (CAP). The CAP measurement, which indicates steatosis, ranged between 100 and 400 dB/m.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Measurements were taken twice baseline and 8 weeks after the intervention.
Results posted on
2025-06-26
Participant Flow
Participant milestones
| Measure |
Energy-restricted Diet
The energy-restricted diet group followed an 8-week long dietary treatment involving 22-25 kcal/kg/day based on ideal body weight.
Energy-restricted dietary intervention: The diets were planned based on current guidelines, manuals, systematic reviews, and meta-analyses published in recent years on MAFLD \[5-6, 27-28\]. In this diet, carbohydrates constituted 50%-55% of total energy intake, proteins constituted 10%-20%, and fats constituted 25%-35%. The content of the diets was tailored to each patient, considering various factors such as sex, age, and physical activity status.
|
Energy + Time-restricted Diet
Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h.
Energy + time-restricted dietary intervention: Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h. Participants were allowed to consume energy-free beverages such as water, coffee, and tea during fasting. The timing of the eating window during the day varied according to participants' lifestyles and habits. However, considering the importance of nocturnal fasting, the eating window in all patients started at 10:00-12:00 in the day and ended at 18:00-20:00 in the evening. The energy-restricted diet group did not follow any time restriction in the planning of main meals and snacks.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
22
|
26
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intermittent Fasting and Metabolic Dysfunction Associated Fatty Liver Disease
Baseline characteristics by cohort
| Measure |
Energy-restricted Diet
n=22 Participants
The energy-restricted diet group followed an 8-week long dietary treatment involving 22-25 kcal/kg/day based on ideal body weight.
Energy-restricted dietary intervention: The diets were planned based on current guidelines, manuals, systematic reviews, and meta-analyses published in recent years on MAFLD \[5-6, 27-28\]. In this diet, carbohydrates constituted 50%-55% of total energy intake, proteins constituted 10%-20%, and fats constituted 25%-35%. The content of the diets was tailored to each patient, considering various factors such as sex, age, and physical activity status.
|
Energy + Time-restricted Diet
n=26 Participants
Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h.
Energy + time-restricted dietary intervention: Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h. Participants were allowed to consume energy-free beverages such as water, coffee, and tea during fasting. The timing of the eating window during the day varied according to participants' lifestyles and habits. However, considering the importance of nocturnal fasting, the eating window in all patients started at 10:00-12:00 in the day and ended at 18:00-20:00 in the evening. The energy-restricted diet group did not follow any time restriction in the planning of main meals and snacks.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
n=5 Participants
|
46.0 years
n=7 Participants
|
49.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Turkish
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
22 participants
n=5 Participants
|
26 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measurements were taken twice baseline and 8 weeks after the intervention.Population: The number of participants completing the study in the groups is equal to the analysis population in the data table.
The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. Hepatic steatosis was defined using controlled attenuation parameter (CAP). The CAP measurement, which indicates steatosis, ranged between 100 and 400 dB/m.
Outcome measures
| Measure |
Energy-restricted Diet
n=22 Participants
The energy-restricted diet group followed an 8-week long dietary treatment involving 22-25 kcal/kg/day based on ideal body weight.
Energy-restricted dietary intervention: The diets were planned based on current guidelines, manuals, systematic reviews, and meta-analyses published in recent years on MAFLD \[5-6, 27-28\]. In this diet, carbohydrates constituted 50%-55% of total energy intake, proteins constituted 10%-20%, and fats constituted 25%-35%. The content of the diets was tailored to each patient, considering various factors such as sex, age, and physical activity status.
|
Energy + Time-restricted Diet
n=26 Participants
Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h.
Energy + time-restricted dietary intervention: Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h. Participants were allowed to consume energy-free beverages such as water, coffee, and tea during fasting. The timing of the eating window during the day varied according to participants' lifestyles and habits. However, considering the importance of nocturnal fasting, the eating window in all patients started at 10:00-12:00 in the day and ended at 18:00-20:00 in the evening. The energy-restricted diet group did not follow any time restriction in the planning of main meals and snacks.
|
|---|---|---|
|
Transient Elastography-Controlled Attenuation Parameter
Baseline
|
319.5 db/m
Interval 296.7 to 371.5
|
343.5 db/m
Interval 297.0 to 363.2
|
|
Transient Elastography-Controlled Attenuation Parameter
8 weeks after the Intervention (End)
|
291.5 db/m
Interval 254.5 to 324.2
|
285.0 db/m
Interval 268.2 to 353.7
|
PRIMARY outcome
Timeframe: Measurements were taken twice baseline and 8 weeks after the intervention.Population: The number of participants completing the study in the groups is equal to the analysis population in the data table.
The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. Hepatic fibrosis were defined using liver stiffness measurement (LSM). LSM measurement ranged between 2.5 and 75 kPa.
Outcome measures
| Measure |
Energy-restricted Diet
n=22 Participants
The energy-restricted diet group followed an 8-week long dietary treatment involving 22-25 kcal/kg/day based on ideal body weight.
Energy-restricted dietary intervention: The diets were planned based on current guidelines, manuals, systematic reviews, and meta-analyses published in recent years on MAFLD \[5-6, 27-28\]. In this diet, carbohydrates constituted 50%-55% of total energy intake, proteins constituted 10%-20%, and fats constituted 25%-35%. The content of the diets was tailored to each patient, considering various factors such as sex, age, and physical activity status.
|
Energy + Time-restricted Diet
n=26 Participants
Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h.
Energy + time-restricted dietary intervention: Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h. Participants were allowed to consume energy-free beverages such as water, coffee, and tea during fasting. The timing of the eating window during the day varied according to participants' lifestyles and habits. However, considering the importance of nocturnal fasting, the eating window in all patients started at 10:00-12:00 in the day and ended at 18:00-20:00 in the evening. The energy-restricted diet group did not follow any time restriction in the planning of main meals and snacks.
|
|---|---|---|
|
Transient Elastography-Liver Stiffness Measurement
Baseline
|
5.5 kpa
Interval 4.2 to 6.2
|
5.7 kpa
Interval 4.6 to 6.9
|
|
Transient Elastography-Liver Stiffness Measurement
8 weeks after the Intervention (End)
|
5.1 kpa
Interval 4.3 to 6.3
|
4.8 kpa
Interval 3.9 to 6.5
|
SECONDARY outcome
Timeframe: Measurements were taken baseline before and 8 weeks after the intervention.Population: The number of participants completing the study in the groups is equal to the analysis population in the data table.
At each time point (baseline and week 8), one serum sample was collected per participant. Serum Fibroblast Growth Factor-21 (FGF-21) levels were analyzed using enzyme-linked immunosorbent assay (ELISA) kits, following the manufacturer's protocols (Human FGF-21 ELISA, Biovendor, Czech Republic).
Outcome measures
| Measure |
Energy-restricted Diet
n=22 Participants
The energy-restricted diet group followed an 8-week long dietary treatment involving 22-25 kcal/kg/day based on ideal body weight.
Energy-restricted dietary intervention: The diets were planned based on current guidelines, manuals, systematic reviews, and meta-analyses published in recent years on MAFLD \[5-6, 27-28\]. In this diet, carbohydrates constituted 50%-55% of total energy intake, proteins constituted 10%-20%, and fats constituted 25%-35%. The content of the diets was tailored to each patient, considering various factors such as sex, age, and physical activity status.
|
Energy + Time-restricted Diet
n=26 Participants
Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h.
Energy + time-restricted dietary intervention: Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h. Participants were allowed to consume energy-free beverages such as water, coffee, and tea during fasting. The timing of the eating window during the day varied according to participants' lifestyles and habits. However, considering the importance of nocturnal fasting, the eating window in all patients started at 10:00-12:00 in the day and ended at 18:00-20:00 in the evening. The energy-restricted diet group did not follow any time restriction in the planning of main meals and snacks.
|
|---|---|---|
|
Serum Fibroblast Growth Factor-21
Baseline
|
316.9 pg/mL
Interval 135.0 to 431.7
|
371.4 pg/mL
Interval 277.7 to 505.1
|
|
Serum Fibroblast Growth Factor-21
8 weeks after the Intervention (End)
|
278.1 pg/mL
Interval 94.8 to 331.6
|
199.1 pg/mL
Interval 109.8 to 459.6
|
SECONDARY outcome
Timeframe: Measurements were taken twice baseline and 8 weeks after the intervention.Population: The number of participants completing the study in the groups is equal to the analysis population in the data table.
At each time point (baseline and week 8), one serum sample was collected per participant. Serum autophagy-related protein-5 (ATG-5) were analyzed using enzyme-linked immunosorbent assay (ELISA) kits, following the manufacturer's protocols (Human Autophagy protein 5 \[ATG5\] ELISA Kit, MyBioSource, Inc. USA).
Outcome measures
| Measure |
Energy-restricted Diet
n=22 Participants
The energy-restricted diet group followed an 8-week long dietary treatment involving 22-25 kcal/kg/day based on ideal body weight.
Energy-restricted dietary intervention: The diets were planned based on current guidelines, manuals, systematic reviews, and meta-analyses published in recent years on MAFLD \[5-6, 27-28\]. In this diet, carbohydrates constituted 50%-55% of total energy intake, proteins constituted 10%-20%, and fats constituted 25%-35%. The content of the diets was tailored to each patient, considering various factors such as sex, age, and physical activity status.
|
Energy + Time-restricted Diet
n=26 Participants
Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h.
Energy + time-restricted dietary intervention: Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h. Participants were allowed to consume energy-free beverages such as water, coffee, and tea during fasting. The timing of the eating window during the day varied according to participants' lifestyles and habits. However, considering the importance of nocturnal fasting, the eating window in all patients started at 10:00-12:00 in the day and ended at 18:00-20:00 in the evening. The energy-restricted diet group did not follow any time restriction in the planning of main meals and snacks.
|
|---|---|---|
|
Serum Autophagy-Related Protein-5
Baseline
|
0.67 ng/ml
Interval 0.56 to 0.79
|
0.74 ng/ml
Interval 0.46 to 1.29
|
|
Serum Autophagy-Related Protein-5
8 weeks after the Intervention (End)
|
0.82 ng/ml
Interval 0.48 to 1.01
|
0.95 ng/ml
Interval 0.73 to 1.32
|
SECONDARY outcome
Timeframe: Measurements were taken twice baseline and 8 weeks after the intervention.Population: The number of participants completing the study in the groups is equal to the analysis population in the data table.
At each time point (baseline and week 8), one serum sample was collected per participant. Serum Beclin-1 were analyzed using enzyme-linked immunosorbent assay (ELISA) kits, following the manufacturer's protocols (Human BECN1 \[Beclin 1\] ELISA Kit, ElabScience, USA).
Outcome measures
| Measure |
Energy-restricted Diet
n=22 Participants
The energy-restricted diet group followed an 8-week long dietary treatment involving 22-25 kcal/kg/day based on ideal body weight.
Energy-restricted dietary intervention: The diets were planned based on current guidelines, manuals, systematic reviews, and meta-analyses published in recent years on MAFLD \[5-6, 27-28\]. In this diet, carbohydrates constituted 50%-55% of total energy intake, proteins constituted 10%-20%, and fats constituted 25%-35%. The content of the diets was tailored to each patient, considering various factors such as sex, age, and physical activity status.
|
Energy + Time-restricted Diet
n=26 Participants
Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h.
Energy + time-restricted dietary intervention: Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h. Participants were allowed to consume energy-free beverages such as water, coffee, and tea during fasting. The timing of the eating window during the day varied according to participants' lifestyles and habits. However, considering the importance of nocturnal fasting, the eating window in all patients started at 10:00-12:00 in the day and ended at 18:00-20:00 in the evening. The energy-restricted diet group did not follow any time restriction in the planning of main meals and snacks.
|
|---|---|---|
|
Serum Beclin-1
Baseline
|
0.18 ng/ml
Interval 0.15 to 0.23
|
0.18 ng/ml
Interval 0.16 to 0.21
|
|
Serum Beclin-1
8 weeks after the Intervention (End)
|
0.19 ng/ml
Interval 0.16 to 0.24
|
0.19 ng/ml
Interval 0.15 to 0.2
|
Adverse Events
Energy-restricted Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Energy + Time-restricted Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place