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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06408610
• Other study ID #: P.T./REC/012/004224
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysbiosis
• Irritable Bowel Syndrome
• Obesity
• Syndrome

Intervention

Other:
• moderate intensity continuous training
exercise and diet

Locations

Country	Name	City	State
Egypt	Faculty of medicine cairo university	Cairo
Egypt	National Nutrition institute	Cairo
Egypt	Faculty of physiotherapy cairo university	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Body Mass Index	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
Secondary	irritable bowel syndrome severity scoring system	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
Secondary	rritable bowel syndrome quality of life questionnaire	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