Moderate Continuous Versus High Interval Intensity Training on Gut Dysbiosis and GLP1 Hormone in IBS

June 9, 2025 updated by: Marwa Saeed Salama, Cairo University

Moderate Continuous Versus High Interval Intensity Training on Gut Dysbiosis and Glucagon Like Peptide Hormone in Irritable Bowel Syndrome

investigating the response of gut bacteria via measuring short chain fatty acids and Glucagon like peptide hormone to two different modes of exercises in pre-diabetic, obese patients with irritable bowel syndrome. It will be hypothesized that there will be no significant difference between the moderate continuous versus high interval intensity training on gut dysbiosis and glucagon like peptide hormone in irritable bowel syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The human gastrointestinal tract represents one of the largest organ between the host, environmental factors and antigens in the human body. In an average life time, around 60 tonnes of food pass through the human GI tract, along with an abundance of microorganisms from the environment which impose a huge threat on gut integrity. The collection of bacteria, archaea and eukarya colonising the GI tract is termed the 'gut microbiota' and has co-evolved with the host over thousands of years to form an intricate and mutually beneficial relationship.The gut microbiota enjoys a mutualistic relationship with the host, harvesting additional energy and nutrients from the diet and protecting the host from pathogens. The resident bacteria produce a wide range of metabolites and chemicals that influence host function and these include short-chain fatty acids such as butyrate, which is essential for the integrity of the colonic epithelium.

However, there is potential for these mechanisms to be disrupted as a result of an altered microbial composition, known as dysbiosis. Human Gut dysbiosis is linked to many pathologic conditions disturbing the energy metabolism; such as obesity and atherosclerosis. The microbiota in the human gut is mostly composed of bacterial phyla: Firmicutes and Bacteroidetes. Firmicutes bacteria are Gram-positive one. It plays a key role in the nutrition and metabolism of the host through SCFA synthesis. Through their metabolic products, Firmicutes bacteria are indirectly connected with other tissues and organs and regulate hunger and satiety. In contrast, Bacteroidetes bacteria are Gram negative and associated with immunomodulation. Increased or decreased Firmicutes / Bacteroidetes (F/B) ratio are associated with the development of obesity or irritable bowel disease (IBD). Short-chain fatty acids (SCFAs), the primary metabolite for colonocytes, are produced in the intestinal lumen by commensal anaerobic bacteria via carbohydrate fermentation. they play a role in preserving gut barrier functions, and have immunomodulatory and anti-inflammatory properties also it regulates the synthesis of the hunger-suppressing hormones leptin, peptide YY, and glucagon- like peptide 1. The gut microbiota can also affect appetite and satiety via vagus nerve activation or immune-neuroendocrine mechanisms. Irritable bowel syndrome (IBS) is a common gastrointestinal disorder characterized by chronic abdominal pain and changes in bowel habits without any known organic causes. Fecal SCFAs abnormalities have been reported in patients with IBS, implying that alterations in SCFAs might be related to IBS. The cause of IBS remains unknown, and no single treatment is found to be universally applicable to all patients with IBS. Among humans, positive correlations were reported between bacterial diversity, butyrate-producing bacteria and cardiorespiratory fitness (VO2max), and higher turnover of carbohydrates and proteins, and concentrations of short-chain fatty acids in athletes compared to sedentary controls. There is also growing evidence that physical activity status and exercise training may shape the gut microbiome.

Physical activity stimulates bacterial community richness by altering SCFAs-producing species, as well as favoring the colonization of health and athletic performance-promoting strains. The ability to promote a bacterial composition capable of protecting the intestinal mucosa also it was found that the effects on gut microbiome seem to gradually disappear when the physical activity is no longer practiced. Moderate aerobic exercise affects the intestinal system mainly through gut immune function gut barrier integrity through tight junction proteins expression and IgA production hypothalamic-pituitary-adrenal (HPA) axis stimulation which, in turn, affects enteric nervous system and intestinal transit time, as well as gut motility, intestinal pH and gut hormones release and bile acids metabolism within enterohepatic circulation. High intensity interval training (HIIT) encompasses exercise prescriptions that are tailored to individual needs and can be used in most any exercise setting. This ability to adapt makes HIIT a valuable tool in the exercise programming of patients with a chronic disease. HIIT has a positive effect on the Bacteroidetes/Firmicutes ratio and also increased the alpha diversity in gut microbiota.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of medicine Cairo University
      • Giza, Egypt
        • Faculty of physiotherapy cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body mass index must be 30-34.9 kg\m
  • Clinical diagnosis of irritable bowel syndrome
  • Must be Pre-diabetic HbA1c of 5.7 - 6.4.
  • Must be sedentary subject

Exclusion Criteria:

  • Communication disorders
  • Gasterointestinal bleeding
  • Antibiotics or probiotics in the last 2 months
  • Recent surgeries in the last 6 months
  • Colorectal cancer or any terminal diseases
  • Fibromylgia or Multiple sclerosis
  • Palpable abdominal mass
  • Cardiovascular diseases
  • Active smokers
  • Musculoskeletal injuries that interfere with exercise program
  • Upper respiratory infections
  • Uncontrolled hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low fermentable short chain carbohydrates diet
Patients will be instructed to follow low fermentable short chain carbohydrates diet (low FODMAP) intervention for 12 weeks limiting daily fermented carbohydrate and dairy products and increase intake of protein, whole grains, fruits and vegetables
Other: moderate intensity continuous training
exercise and diet
Other Names:
  • high intensity interval training
  • low fermentable short chain carbohydrates diet (low FODMAP)
Experimental: moderate intensity continuous training

Patients will receive moderate intensity continuous training The program will be in form of Frequency Moderate continues training will be scheduled 3 times per week for 12 weeks Intensity 65-75% of target heart rate.

Duration 40 minutes per session.
Other: moderate intensity continuous training
exercise and diet
Other Names:
  • high intensity interval training
  • low fermentable short chain carbohydrates diet (low FODMAP)
Experimental: high intensity interval training
Patients will receive high intensity interval training. The program will be in form of Frequency: High intensity interval training will be scheduled 3 times per week for 12 week Intensity 90% of target heart rate including 10 bouts of 1 minute interspersed with 10 bouts of 1 minute of active recovery 50% of target heart rate. Duration the session will last 30 minutes includes warming up and cooling down periods.
Other: moderate intensity continuous training
exercise and diet
Other Names:
  • high intensity interval training
  • low fermentable short chain carbohydrates diet (low FODMAP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Chain fatty acids
Time Frame: before the start of the trial and at the end of the trial 3 months
fecal sample will be separated. Applying four analytes, including total SCFAs, acetate, propionate, and butyrate, will be targeted. Final concentrations will be calculated based on internal standards and are expressed as micromoles per gram of wet feces (μmol/g). Techniques and predictive approaches will be used across. gas chromatography will be used to quantify Short Chain Fatty Acids (SCFAs) from fecal samples
before the start of the trial and at the end of the trial 3 months
Glucagon like peptide hormone
Time Frame: before the start of the trial and at the end of the trial 3 months
Glucagon like peptide hormone will be measure with Elisa Kit an Enzyme-Linked Immunosorbent Assay. The plate will be pre-coated with Human GLP-1 antibody
before the start of the trial and at the end of the trial 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index
Time Frame: before the start of the trial and at the end of the trial 3 months
weight and height will be recorded to calculate body mass index (BMI) according to the following equation BMI= weight/height2 (Kg/m2)
before the start of the trial and at the end of the trial 3 months
irritable bowel syndrome severity scoring system
Time Frame: before the start of the trial and at the end of the trial 3 months
This five-item questionnaire will measure IBS symptom severity by addressing abdominal pain (frequency and severity), bloating, dissatisfaction with bowel habits, and interference with daily activities. Each question score ranges from 0 to 100 and a higher score indicates more severe GI symptoms. A total score of 75-175 represents mild IBS, 176-300 moderate IBS and >300 severe IBS
before the start of the trial and at the end of the trial 3 months
rritable bowel syndrome quality of life questionnaire
Time Frame: before the start of the trial and at the end of the trial 3 months

The IBS-QoL is a condition-specific instrument will be used to assess the impact of IBS and effects of treatment. It consists of 34 questions which cover eight domains including dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationships. Each item has a five-point response scale (not at all, slightly, moderately, quite a bit, extremely).

The responses are summed and averaged for a total score and transformed to a scale between 0 and 100: higher scores indicating better IBS-specific QoL
before the start of the trial and at the end of the trial 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Donia M Elmasry, Doctorate, Faculty of physiotherapy cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

May 15, 2025

Study Completion (Actual)

May 17, 2025

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 9, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T./REC/012/004224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocol and final results

IPD Sharing Time Frame

May 2024 till March 2025

IPD Sharing Access Criteria

Researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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