The Role of Regular Physical Activity in Enhancing Metabolic Health, Reducing Inflammation, and Improving Gut Function

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.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Metabolic Disease; Intestinal Inflammation
• Intervention / Treatment: Other: Exercise

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznań, Poland, 60-213
    • Poznań University of Physical Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age over 50 years
• No contraindications for engaging in physical activity

Exclusion Criteria:

• Presence of diseases that prevent participation in physical activity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: excercise; supervised excercise training; twice a week for 12 months	Other: Exercise; supervised exercise training; twice a week for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in insulin sensitivity	To assess the primary outcome measure of improvement in insulin sensitivity, we will use the HOMA-IR index.	before and after 12 months of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before and after 12 months of intervention

Collaborators and Investigators

• Sponsor: Poznan University of Physical Education
• Investigators: Study Director: Ewa Bryl, PhD, Poznan Univeristy of Physical Education

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; older adults; inflammation; gut function; metabolic health
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Metabolic Diseases
• Other Study ID Numbers: 423/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No