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

NCT06408610 | Completed DMC

• 1 other identifier: P.T./REC/012/004224
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Irritable Bowel Syndrome; Obesity; Dysbiosis

Outcome Measures

Primary Outcomes (2)

• Short Chain fatty acids

  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

  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 Outcomes (3)

• Body Mass Index

  before the start of the trial and at the end of the trial 3 months

• irritable bowel syndrome severity scoring system

  before the start of the trial and at the end of the trial 3 months

• rritable bowel syndrome quality of life questionnaire

  before the start of the trial and at the end of the trial 3 months

Study Arms (3)

moderate intensity continuous training

EXPERIMENTAL

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

high intensity interval training

EXPERIMENTAL

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

low fermentable short chain carbohydrates diet

EXPERIMENTAL

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

Interventions

moderate intensity continuous training OTHER

exercise and diet

Also known as: high intensity interval training, low fermentable short chain carbohydrates diet (low FODMAP)

high intensity interval training; low fermentable short chain carbohydrates diet; moderate intensity continuous training

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of medicine cairo university

Cairo, Egypt

Location

Faculty of physiotherapy cairo university

Giza, Egypt

Location

Related Publications (26)

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• Kuhre RE, Wewer Albrechtsen NJ, Hartmann B, Deacon CF, Holst JJ. Measurement of the incretin hormones: glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. J Diabetes Complications. 2015 Apr;29(3):445-50. doi: 10.1016/j.jdiacomp.2014.12.006. Epub 2014 Dec 15.

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• Lin L, Zhang J. Role of intestinal microbiota and metabolites on gut homeostasis and human diseases. BMC Immunol. 2017 Jan 6;18(1):2. doi: 10.1186/s12865-016-0187-3.

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MeSH Terms

Conditions

Irritable Bowel Syndrome; Obesity; Dysbiosis

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Donia M Elmasry, Doctorate

  Faculty of physiotherapy Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Model Details: 1. Patients will receive moderate intensity continuous training (MICT) 2. Patients will receive high intensity interval training (HIIT) 3. Patients will be instructed to follow low fermentable short chain carbohydrates diet (low FODMAP)

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: May 1, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 17, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: May 2024 till March 2025
• Access Criteria: Researchers

Locations

EG (2)