Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606678
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
The Role of Regular Physical Activity in Enhancing Metabolic Health Reducing Inflammation and Improving Gut Function
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Role of Regular Physical Activity in Promoting Metabolic Health Reducing Inflammation and Improving Gut Function in Individuals Aged 50 Years and Older
Status:
ENROLLING_BY_INVITATION
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:
None
Brief Summary:
The goal of this clinical trial is to learn if regular physical activity can improve metabolic health reduce inflammation and decrease gut permeability in individuals aged 50 and older The main questions it aims to answer are
Does regular physical activity even at low intensity improve metabolic parameters Does physical activity reduce inflammation and gut permeability in older adults Researchers will compare a group participating in low-intensity dance classes to a group participating in higher-intensity calisthenics training to see if the intensity of exercise has different effects on these outcomes
Participants will be asked to
Attend organized training sessions led by instructors twice a week for 12 months
Complete anthropometric measurements height weight and body composition analysis DXA scan
Provide blood samples for biochemical analysis glucose insulin CRP etc Submit stool samples for gut health markers calprotectin zonulin etc Complete surveys on lifestyle and dietary habits before and after the study
Does regular physical activity even at low intensity improve metabolic parameters Does physical activity reduce inflammation and gut permeability in older adults Researchers will compare a group participating in low-intensity dance classes to a group participating in higher-intensity calisthenics training to see if the intensity of exercise has different effects on these outcomes
Participants will be asked to
Attend organized training sessions led by instructors twice a week for 12 months
Complete anthropometric measurements height weight and body composition analysis DXA scan
Provide blood samples for biochemical analysis glucose insulin CRP etc Submit stool samples for gut health markers calprotectin zonulin etc Complete surveys on lifestyle and dietary habits before and after the study
Detailed Description:
The project aims to assess the impact of increased physical activity on inflammation and gut permeability and consequently on metabolic health in individuals
Hypothesis Regular physical activity even at low intensity improves metabolic parameters and reduces gut inflammation thus positively affecting the health of individuals
Description The study will involve individuals aged 50 and older The experimental group will consist of 50 participants who will engage in organized exercise sessions led by trainers twice a week for 12 months and 50 participants who will not participate in sports activities Participants will be assessed twice before the start of the exercise program and after completing the 12 month training program Participants will be recruited into two groups differing in training intensity One group will participate in low-intensity dance classes while the other group will engage in calisthenics body weight resistance training at a higher intensity
The study will include anthropometric measurements body composition analysis surveys biochemical tests and stool sample analysis Height will be measured using a GMP Swiss Made anthropometer accuracy 1mm body weight with an electronic personal scale RADWAG C31560150OW-1 accuracy 100g and body composition will be assessed using dual-energy X-ray absorptiometry DXA with the Lunar Prodigy device General Electric Medical Systems USA Lifestyle and dietary habits will be assessed using a questionnaire method The food frequency questionnaire FFQ and food diaries participants will be asked to record their intake for 3 days before the start and 3 days after the completion of the training program will be used
Biochemical blood tests will measure glucose insulin amylin C-peptide ghrelin glucose-dependent insulinotropic peptide GIP glucagon-like peptide-1 GLP-1 leptin and secretin as markers of metabolic changes as well as C-reactive protein CRP calprotectin zonulin and secretory immunoglobulin A as markers of inflammation and gut permeability The measurement of metabolic markers will be performed using commercially available Multiplex kits based on magnetic bead technology allowing for a broader range of results with a smaller volume of biological material and lower overall cost The assessment of inflammation and gut permeability markers will be performed using commercially available ELISA kits Based on fasting glucose and insulin levels the insulin sensitivity index HOMA-IR will be calculated
Hypothesis Regular physical activity even at low intensity improves metabolic parameters and reduces gut inflammation thus positively affecting the health of individuals
Description The study will involve individuals aged 50 and older The experimental group will consist of 50 participants who will engage in organized exercise sessions led by trainers twice a week for 12 months and 50 participants who will not participate in sports activities Participants will be assessed twice before the start of the exercise program and after completing the 12 month training program Participants will be recruited into two groups differing in training intensity One group will participate in low-intensity dance classes while the other group will engage in calisthenics body weight resistance training at a higher intensity
The study will include anthropometric measurements body composition analysis surveys biochemical tests and stool sample analysis Height will be measured using a GMP Swiss Made anthropometer accuracy 1mm body weight with an electronic personal scale RADWAG C31560150OW-1 accuracy 100g and body composition will be assessed using dual-energy X-ray absorptiometry DXA with the Lunar Prodigy device General Electric Medical Systems USA Lifestyle and dietary habits will be assessed using a questionnaire method The food frequency questionnaire FFQ and food diaries participants will be asked to record their intake for 3 days before the start and 3 days after the completion of the training program will be used
Biochemical blood tests will measure glucose insulin amylin C-peptide ghrelin glucose-dependent insulinotropic peptide GIP glucagon-like peptide-1 GLP-1 leptin and secretin as markers of metabolic changes as well as C-reactive protein CRP calprotectin zonulin and secretory immunoglobulin A as markers of inflammation and gut permeability The measurement of metabolic markers will be performed using commercially available Multiplex kits based on magnetic bead technology allowing for a broader range of results with a smaller volume of biological material and lower overall cost The assessment of inflammation and gut permeability markers will be performed using commercially available ELISA kits Based on fasting glucose and insulin levels the insulin sensitivity index HOMA-IR will be calculated
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