Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06186869
Status:
RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-11-09
Brief Title:
Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD
Sponsor:
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Organization:
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Study Overview
Official Title:
Effects of Two Different Exercise Programs Combined With the Mediterranean Diet on Inflammatory Status in Subjects With Obesity and NAFLD
Status:
RECRUITING
Status Verified Date:
2023-12
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:
Obesity_AF
Brief Summary:
The aim of the study is to estimate the effectiveness of two different exercise programs combined with the Mediterranean diet versus diet alone on inflammatory status in subjects aged 18-65 years with obesity BMI30 and Non-Alcoholic Fatty Liver Disease NAFLD CAP 248 dBm
Detailed Description:
The main objective of the study is to estimate the effect of two exercise programs of different type and intensity combined with a Low Glycaemic Index Mediterranean Diet LGIMD compared to diet alone on the systemic inflammation index SII and biomarkers related to the inflammatory state TNF-alpha IL-1 IL-6 IL-10 CK-18 PCR and VES in patients with obesity and NAFLD aged 18-65 years after a 4-month intervention
The secondary objectives are to assess whether the adoption of the two exercise programs of different types and intensities associated with an LGIMD compared to diet alone in patients with obesity and NAFLD can significantly modify body composition inhibiting the risk of sarcopenia in turn favored by NAFLD improve physical efficiency fitness understood as cardio-respiratory fitness muscular strength and flexibility may also lead to improvements regarding the gut microbiota in terms of abundance of microbial taxa by studying starting from the data obtained from the 16S the metabolic pathways of the microbiota and fecal metabolome as well as Quality of Life by filling in specific questionnaires and the evaluation of the fatty acid profile of erythrocyte membranes
The two different types of exercise will be - outdoor walking understood as a moderate-intensity aerobic exercise carried out 4 times a week for a duration of 60 minutes for 4 months - High-Intensity Interval Training carried out 3 times a week for a period of 50 minutes at a time for 4 months in a gymnasium affiliated with the organization
The diet will be the same for all project participants and will follow advice based on the Low Glycaemic Index Mediterranean Diet All subjects will be followed by specialized personnel regarding both diet and exercise
The secondary objectives are to assess whether the adoption of the two exercise programs of different types and intensities associated with an LGIMD compared to diet alone in patients with obesity and NAFLD can significantly modify body composition inhibiting the risk of sarcopenia in turn favored by NAFLD improve physical efficiency fitness understood as cardio-respiratory fitness muscular strength and flexibility may also lead to improvements regarding the gut microbiota in terms of abundance of microbial taxa by studying starting from the data obtained from the 16S the metabolic pathways of the microbiota and fecal metabolome as well as Quality of Life by filling in specific questionnaires and the evaluation of the fatty acid profile of erythrocyte membranes
The two different types of exercise will be - outdoor walking understood as a moderate-intensity aerobic exercise carried out 4 times a week for a duration of 60 minutes for 4 months - High-Intensity Interval Training carried out 3 times a week for a period of 50 minutes at a time for 4 months in a gymnasium affiliated with the organization
The diet will be the same for all project participants and will follow advice based on the Low Glycaemic Index Mediterranean Diet All subjects will be followed by specialized personnel regarding both diet and exercise
Study Oversight
Has Oversight DMC:
None
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?:
None