Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615817
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Intermittent Fasting Mediterranean Diet and NAFLD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison Between 1410 Intermittent Fasting and the Southern Italian Mediterranean Diet in the Variation of NAFLD Score Inflammatory Indices and Intestinal Microbiota
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RC2024-21
Brief Summary:
This study aims to evaluate the effects of Intermittent Fasting IF 1410 compared with the Low Glycemic Index Mediterranean Diet on NAFLD
Detailed Description:
Interventional randomized controlled 2-arm clinical trial
The two study arms are
Low-Glycemic Index Mediterranean Diet Control Arm
IF 1410 Experimental Arm with 14 hours of overnight fasting and 10 hours of feeding with Low Glycemic Index Mediterranean Diet
The study involves the enrollment of 60 subjects 30 in each arm with NAFLD mediumsevere grade diagnosed by Fibroscan randomly assigned using randomization tables to one of the two study arms
The duration of the nutritional intervention is 4 months During the study duration period patients will undergo 3 visits
At T0 Screening Visit patients who are potentially enrollable after signing the informed consent will undergo
Medical history family physiological remote and upcoming pathological and pharmacological
Fibroscan to assess the degree of hepatic steatosis
Survey of anthropometric characteristics BMI abdominal circumference neck circumference
Bioimpedance examination
NuWell Nutrition Wellness Survey questionnaire completion
IPAQ Daily Physical Activity Questionnaire questionnaire
In case the inclusion criteria are met the enrolled patients will be randomized using randomization tables into one of the two arms under the study
The enrolled patients will be invited to return after 7 days to complete T0 and receive the personalized food plan depending on the arm they belong to and anthropometric characteristics
Fasting for at least 12 hours they will undergo blood sampling by venipuncture and body composition assessment by DEXA
Enrolled subjects will be asked to bring a stool sample and a urine sample for fecal and urinary mycriobiota and metabolome analysis
Patients will be given the Food Diary which must be reported completed at each visit
After 2 months from the start of treatment T0 60gg patients will be called for T1
At this visit patients who have been fasting for at least 12 hours will undergo
Samples by venous puncture
Bioimpedance examination
Anthropometric measurements Patients will be asked to bring a stool sample and a urine sample and the Food Diary will be checked
After another 2 months T1 60gg End of treatment patients will be called for T2
At this visit patients fasting for at least 12 hours will undergo
Samples by venous puncture
Fibroscan
Bioimpedance examination
DEXA
Anthropometric measurements Patients will be asked to bring a stool sample and a urine sample and a Food Diary will be collected
The blood sample taken will be used to assay routine hematochemical parameters and nutritional metabolic and cardiovascular risk Specifically the following will be assayed blood glucose glycated hemoglobin insulin azotemia creatinine total cholesterol LDL cholesterol HDL cholesterol triglycerides urate AST ALT gamma GT total protein protein electrophoresis high-sensitivity PCR TSH FT3 FT4 blood count ferritin vitamin D prolactin cortisol urine tests IL 1 4 6 8 10 CK18 and TNFα
Patients will be given the reports of Routine blood tests only Fibroscan Bioimpedance Examination and DEXA
The two study arms are
Low-Glycemic Index Mediterranean Diet Control Arm
IF 1410 Experimental Arm with 14 hours of overnight fasting and 10 hours of feeding with Low Glycemic Index Mediterranean Diet
The study involves the enrollment of 60 subjects 30 in each arm with NAFLD mediumsevere grade diagnosed by Fibroscan randomly assigned using randomization tables to one of the two study arms
The duration of the nutritional intervention is 4 months During the study duration period patients will undergo 3 visits
At T0 Screening Visit patients who are potentially enrollable after signing the informed consent will undergo
Medical history family physiological remote and upcoming pathological and pharmacological
Fibroscan to assess the degree of hepatic steatosis
Survey of anthropometric characteristics BMI abdominal circumference neck circumference
Bioimpedance examination
NuWell Nutrition Wellness Survey questionnaire completion
IPAQ Daily Physical Activity Questionnaire questionnaire
In case the inclusion criteria are met the enrolled patients will be randomized using randomization tables into one of the two arms under the study
The enrolled patients will be invited to return after 7 days to complete T0 and receive the personalized food plan depending on the arm they belong to and anthropometric characteristics
Fasting for at least 12 hours they will undergo blood sampling by venipuncture and body composition assessment by DEXA
Enrolled subjects will be asked to bring a stool sample and a urine sample for fecal and urinary mycriobiota and metabolome analysis
Patients will be given the Food Diary which must be reported completed at each visit
After 2 months from the start of treatment T0 60gg patients will be called for T1
At this visit patients who have been fasting for at least 12 hours will undergo
Samples by venous puncture
Bioimpedance examination
Anthropometric measurements Patients will be asked to bring a stool sample and a urine sample and the Food Diary will be checked
After another 2 months T1 60gg End of treatment patients will be called for T2
At this visit patients fasting for at least 12 hours will undergo
Samples by venous puncture
Fibroscan
Bioimpedance examination
DEXA
Anthropometric measurements Patients will be asked to bring a stool sample and a urine sample and a Food Diary will be collected
The blood sample taken will be used to assay routine hematochemical parameters and nutritional metabolic and cardiovascular risk Specifically the following will be assayed blood glucose glycated hemoglobin insulin azotemia creatinine total cholesterol LDL cholesterol HDL cholesterol triglycerides urate AST ALT gamma GT total protein protein electrophoresis high-sensitivity PCR TSH FT3 FT4 blood count ferritin vitamin D prolactin cortisol urine tests IL 1 4 6 8 10 CK18 and TNFα
Patients will be given the reports of Routine blood tests only Fibroscan Bioimpedance Examination and DEXA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None