Intestinal InflammationNCT06606678
The Role of Regular Physical Activity in Enhancing Metabolic Health, Reducing Inflammation, and Improving Gut Function
A study testing Exercise in people with Intestinal Inflammation and Metabolic Disease, run by Poznan University of Physical Education at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intestinal Inflammation, Metabolic Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePoland
- Study dates
- 17 Sep 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 50 years
- No contraindications for engaging in physical activity
Who cannot join
- Presence of diseases that prevent participation in physical activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
Read the 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 C315.60/150.OW-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.
- Conditions
- Intestinal Inflammation, Metabolic Disease
- Being tested
- Exercise
- Keywords
- physical activity, metabolic health, inflammation, gut function, older adults
- Medical subject headings
- Metabolic Diseases, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
supervised exercise training; twice a week for 12 months
| Study group | Role | What they receive |
|---|---|---|
| excercise | Experimental | supervised excercise training; twice a week for 12 months Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in insulin sensitivity
To assess the primary outcome measure of improvement in insulin sensitivity, we will use the HOMA-IR index.
Measured: before and after 12 months of intervention
Secondary outcomes (1)
Reduction in gut inflammation
Reduction in gut inflammation will be assessed by measuring decreases in biomarkers such as calprotectin, zonulin, and secretory immunoglobulin A in stool samples/blood samples using ELISA kits.
Measured: before and after 12 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start17 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewa Bryl, PhD, Study director, Poznan Univeristy of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606678
- Sponsor's protocol ID
- 423/24
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06606678
- Acronym / sponsor ID
- 423/24
- Conditions
- Intestinal Inflammation, Metabolic Disease
- Keywords
- physical activity, metabolic health, inflammation, gut function, older adults
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 C315.60/150.OW-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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| excercise | Experimental | Other: Exercisesupervised excercise training; twice a week for 12 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 50 years
- No contraindications for engaging in physical activity
Key exclusion criteria (1 listed)
- Presence of diseases that prevent participation in physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercisesupervised exercise training; twice a week for 12 months | Other | excercise |
Primary outcome
Improvement in insulin sensitivity
Time frame: before and after 12 months of intervention
To assess the primary outcome measure of improvement in insulin sensitivity, we will use the HOMA-IR index.
1 secondary outcome
Reduction in gut inflammation
Time frame: before and after 12 months of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ewa Bryl, PhD study director
Poznan Univeristy of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Intestinal Inflammation and Metabolic Disease, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in insulin sensitivity (time frame: before and after 12 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.