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

NCT ID: NCT06408610

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-05-17

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.

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.

Conditions

Irritable Bowel Syndrome; Obesity; Dysbiosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

moderate intensity continuous training

Intervention Type: OTHER

exercise and diet

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.

Group Type: EXPERIMENTAL

moderate intensity continuous training

Intervention Type: OTHER

exercise and diet

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

Group Type: EXPERIMENTAL

moderate intensity continuous training

Intervention Type: OTHER

exercise and diet

Interventions

moderate intensity continuous training

exercise and diet

Intervention Type: OTHER

Other Intervention Names

high intensity interval training; low fermentable short chain carbohydrates diet (low FODMAP)

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Saeed Salama

PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donia M Elmasry, Doctorate

Role: STUDY_DIRECTOR

Faculty of physiotherapy Cairo University

Locations

Faculty of medicine cairo university

Cairo, , Egypt

Faculty of physiotherapy cairo university

Giza, , Egypt

Countries

Egypt

References

Aziz I, Simren M. The overlap between irritable bowel syndrome and organic gastrointestinal diseases. Lancet Gastroenterol Hepatol. 2021 Feb;6(2):139-148. doi: 10.1016/S2468-1253(20)30212-0. Epub 2020 Nov 13.

Reference Type: BACKGROUND

PMID: 33189181 (View on PubMed)

Cataldi S, Poli L, Sahin FN, Patti A, Santacroce L, Bianco A, Greco G, Ghinassi B, Di Baldassarre A, Fischetti F. The Effects of Physical Activity on the Gut Microbiota and the Gut-Brain Axis in Preclinical and Human Models: A Narrative Review. Nutrients. 2022 Aug 11;14(16):3293. doi: 10.3390/nu14163293.

Reference Type: BACKGROUND

PMID: 36014798 (View on PubMed)

Cella V, Bimonte VM, Sabato C, Paoli A, Baldari C, Campanella M, Lenzi A, Ferretti E, Migliaccio S. Nutrition and Physical Activity-Induced Changes in Gut Microbiota: Possible Implications for Human Health and Athletic Performance. Foods. 2021 Dec 10;10(12):3075. doi: 10.3390/foods10123075.

Reference Type: BACKGROUND

PMID: 34945630 (View on PubMed)

Chen L, Sun X, Khalsa AS, Bailey MT, Kelleher K, Spees C, Zhu J. Accurate and reliable quantitation of short chain fatty acids from human feces by ultra high-performance liquid chromatography-high resolution mass spectrometry (UPLC-HRMS). J Pharm Biomed Anal. 2021 Jun 5;200:114066. doi: 10.1016/j.jpba.2021.114066. Epub 2021 Apr 6.

Reference Type: BACKGROUND

PMID: 33866297 (View on PubMed)

Clark T, Morey R, Jones MD, Marcos L, Ristov M, Ram A, Hakansson S, Franklin A, McCarthy C, De Carli L, Ward R, Keech A. High-intensity interval training for reducing blood pressure: a randomized trial vs. moderate-intensity continuous training in males with overweight or obesity. Hypertens Res. 2020 May;43(5):396-403. doi: 10.1038/s41440-019-0392-6. Epub 2020 Jan 14.

Reference Type: BACKGROUND

PMID: 31937915 (View on PubMed)

DeGruttola AK, Low D, Mizoguchi A, Mizoguchi E. Current Understanding of Dysbiosis in Disease in Human and Animal Models. Inflamm Bowel Dis. 2016 May;22(5):1137-50. doi: 10.1097/MIB.0000000000000750.

Reference Type: BACKGROUND

PMID: 27070911 (View on PubMed)

Denou E, Marcinko K, Surette MG, Steinberg GR, Schertzer JD. High-intensity exercise training increases the diversity and metabolic capacity of the mouse distal gut microbiota during diet-induced obesity. Am J Physiol Endocrinol Metab. 2016 Jun 1;310(11):E982-93. doi: 10.1152/ajpendo.00537.2015. Epub 2016 Apr 26.

Reference Type: BACKGROUND

PMID: 27117007 (View on PubMed)

Elhosseiny D, Mahmoud NE, Manzour AF. Factors associated with irritable bowel syndrome among medical students at Ain Shams University. J Egypt Public Health Assoc. 2019 Dec 4;94(1):23. doi: 10.1186/s42506-019-0023-8.

Reference Type: BACKGROUND

PMID: 32813140 (View on PubMed)

Gupta AK, Maity C. Efficacy and safety of Bacillus coagulans LBSC in irritable bowel syndrome: A prospective, interventional, randomized, double-blind, placebo-controlled clinical study [CONSORT Compliant]. Medicine (Baltimore). 2021 Jan 22;100(3):e23641. doi: 10.1097/MD.0000000000023641.

Reference Type: BACKGROUND

PMID: 33545934 (View on PubMed)

Koh A, De Vadder F, Kovatcheva-Datchary P, Backhed F. From Dietary Fiber to Host Physiology: Short-Chain Fatty Acids as Key Bacterial Metabolites. Cell. 2016 Jun 2;165(6):1332-1345. doi: 10.1016/j.cell.2016.05.041.

Reference Type: BACKGROUND

PMID: 27259147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25623632 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28061847 (View on PubMed)

Mohammed AA, Moustafa HA, Nour-Eldein H, Saudi RA. Association of anxiety-depressive disorders with irritable bowel syndrome among patients attending a rural family practice center: a comparative cross-sectional study. Gen Psychiatr. 2021 Dec 13;34(6):e100553. doi: 10.1136/gpsych-2021-100553. eCollection 2021.

Reference Type: BACKGROUND

PMID: 34970639 (View on PubMed)

Monda V, Villano I, Messina A, Valenzano A, Esposito T, Moscatelli F, Viggiano A, Cibelli G, Chieffi S, Monda M, Messina G. Exercise Modifies the Gut Microbiota with Positive Health Effects. Oxid Med Cell Longev. 2017;2017:3831972. doi: 10.1155/2017/3831972. Epub 2017 Mar 5.

Reference Type: BACKGROUND

PMID: 28357027 (View on PubMed)

Portincasa P, Bonfrate L, Vacca M, De Angelis M, Farella I, Lanza E, Khalil M, Wang DQ, Sperandio M, Di Ciaula A. Gut Microbiota and Short Chain Fatty Acids: Implications in Glucose Homeostasis. Int J Mol Sci. 2022 Jan 20;23(3):1105. doi: 10.3390/ijms23031105.

Reference Type: BACKGROUND

PMID: 35163038 (View on PubMed)

Prince SA, Cardilli L, Reed JL, Saunders TJ, Kite C, Douillette K, Fournier K, Buckley JP. A comparison of self-reported and device measured sedentary behaviour in adults: a systematic review and meta-analysis. Int J Behav Nutr Phys Act. 2020 Mar 4;17(1):31. doi: 10.1186/s12966-020-00938-3.

Reference Type: BACKGROUND

PMID: 32131845 (View on PubMed)

Resende AS, Leite GSF, Lancha Junior AH. Changes in the Gut Bacteria Composition of Healthy Men with the Same Nutritional Profile Undergoing 10-Week Aerobic Exercise Training: A Randomized Controlled Trial. Nutrients. 2021 Aug 18;13(8):2839. doi: 10.3390/nu13082839.

Reference Type: BACKGROUND

PMID: 34444999 (View on PubMed)

Rettedal EA, Cree JME, Adams SE, MacRae C, Skidmore PML, Cameron-Smith D, Gant N, Blenkiron C, Merry TL. Short-term high-intensity interval training exercise does not affect gut bacterial community diversity or composition of lean and overweight men. Exp Physiol. 2020 Aug;105(8):1268-1279. doi: 10.1113/EP088744. Epub 2020 Jun 17.

Reference Type: BACKGROUND

PMID: 32478429 (View on PubMed)

Shukohifar M, Mozafari Z, Rahmanian M, Mirzaei M. Performance of body mass index and body fat percentage in predicting metabolic syndrome risk factors in diabetic patients of Yazd, Iran. BMC Endocr Disord. 2022 Aug 31;22(1):216. doi: 10.1186/s12902-022-01125-0.

Reference Type: BACKGROUND

PMID: 36045359 (View on PubMed)

Singh R, Zogg H, Wei L, Bartlett A, Ghoshal UC, Rajender S, Ro S. Gut Microbial Dysbiosis in the Pathogenesis of Gastrointestinal Dysmotility and Metabolic Disorders. J Neurogastroenterol Motil. 2021 Jan 30;27(1):19-34. doi: 10.5056/jnm20149.

Reference Type: BACKGROUND

PMID: 33166939 (View on PubMed)

Song BK, Kim YS, Kim HS, Oh JW, Lee O, Kim JS. Combined exercise improves gastrointestinal motility in psychiatric in patients. World J Clin Cases. 2018 Aug 16;6(8):207-213. doi: 10.12998/wjcc.v6.i8.207.

Reference Type: BACKGROUND

PMID: 30148149 (View on PubMed)

Stojanov S, Berlec A, Strukelj B. The Influence of Probiotics on the Firmicutes/Bacteroidetes Ratio in the Treatment of Obesity and Inflammatory Bowel disease. Microorganisms. 2020 Nov 1;8(11):1715. doi: 10.3390/microorganisms8111715.

Reference Type: BACKGROUND

PMID: 33139627 (View on PubMed)

Sun Q, Jia Q, Song L, Duan L. Alterations in fecal short-chain fatty acids in patients with irritable bowel syndrome: A systematic review and meta-analysis. Medicine (Baltimore). 2019 Feb;98(7):e14513. doi: 10.1097/MD.0000000000014513.

Reference Type: BACKGROUND

PMID: 30762787 (View on PubMed)

Thursby E, Juge N. Introduction to the human gut microbiota. Biochem J. 2017 May 16;474(11):1823-1836. doi: 10.1042/BCJ20160510.

Reference Type: BACKGROUND

PMID: 28512250 (View on PubMed)

Varney J, Barrett J, Scarlata K, Catsos P, Gibson PR, Muir JG. FODMAPs: food composition, defining cutoff values and international application. J Gastroenterol Hepatol. 2017 Mar;32 Suppl 1:53-61. doi: 10.1111/jgh.13698.

Reference Type: BACKGROUND

PMID: 28244665 (View on PubMed)

Wang L, Alammar N, Singh R, Nanavati J, Song Y, Chaudhary R, Mullin GE. Gut Microbial Dysbiosis in the Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis of Case-Control Studies. J Acad Nutr Diet. 2020 Apr;120(4):565-586. doi: 10.1016/j.jand.2019.05.015. Epub 2019 Aug 28.

Reference Type: BACKGROUND

PMID: 31473156 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

P.T./REC/012/004224

Identifier Type: -

Identifier Source: org_study_id