Response of Irritable Bowel Syndrome to Abdominal Fat Reduction

NCT05879692 | Unknown

• 1 other identifier: P.T.REC/012/004475
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to find out the response of Irritable Bowel Syndrome (IBS) to abdominal fat reduction in central obese patients using: application of High Intensity Focused Ultrasound (cavitation) on the abdominal region, aerobic exercise and a dietary regimen that will be low in calories (Low Caloric Diet) and low in fermentable oligo-, di-, mono- saccharides and polyols (low-FODMAPs).

Conditions

Irritable Bowel Syndrome; Obesity; Abdominal Obesity

Keywords

Irritable Bowel Syndrome; abdominal fat; central obesity; high intensity focused ultrasound; FODMAPs diet

Outcome Measures

Primary Outcomes (5)

• change in total body fat percentage

  total body fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)

  change from baseline total body fat percentage at 12 weeks

• change in abdominal subcutaneous fat percentage

  abdominal subcutaneous fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)

  change from baseline abdominal subcutaneous fat percentage at 12 weeks

• change in abdominal visceral fat percentage

  abdominal visceral fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)

  change from baseline abdominal visceral fat percentage at 12 weeks

• change in Irritable bowel syndrome Severity Scoring system (IBS-SSS)

  The Irritable bowel syndrome Severity Scoring System (IBS-SSS) questionnaire was validated by Francis et al. in 1997and consists of five questions that measure: (1) abdominal pain severity; (2) frequency (number of days in every 10 days) with abdominal pain; (3) abdominal bloating/distension; (4) satisfaction with bowel habits; (5) IBS-related quality of life (QoL). Each measure is rated from 0 to 100, with total scores ranging from 0 to 500

  change from baseline Irritable bowel syndrome Severity Scoring system at 12 weeks

• change in Irritable bowel syndrome-quality of life (IBS-QOL)

  The Irritable bowel syndrome-quality of life questionnaire (IBS-QOL) consists of 34 items assessing patients' well-being across eight subscales: dysphoria (eight items); interference with activity (seven items); body image (four items); social reaction (four items); health worry (three items); food avoidance (three items); relationships (three items); and sexual (two items)

  change from baseline Irritable bowel syndrome-quality of life at 12 weeks

Secondary Outcomes (3)

• change in body weight

  change from baseline body weight at 12 weeks

• change in body mass index

  change from baseline body mass index at 12 weeks

• change in waist circumference measurement

  change from baseline Waist circumference at 12 weeks

Study Arms (2)

study group (Group A)

EXPERIMENTAL

Will consist of 30 cases suffering from mild to moderate Irritable Bowel Syndrome (IBS) with mild to moderate obesity will receive High Intensity Focused Ultrasound (Cavitation), a dietary regimen that combines Low Caloric Diet (LCD) and low (FODMAPs) diet and aerobic exercises with moderate intensity.

Procedure: focused ultrasound; Behavioral: Low Caloric Diet (LCD) and a low (FODMAPs) diet; Other: aerobic exercise

control group (Group B)

ACTIVE COMPARATOR

Will consist of 30 cases suffering from mild to moderate Irritable Bowel Syndrome (IBS) with mild to moderate obesity will receive only the same dietary regimen and aerobic exercise that prescribed for group A.

Behavioral: Low Caloric Diet (LCD) and a low (FODMAPs) diet; Other: aerobic exercise

Interventions

focused ultrasound PROCEDURE

focused ultra sound cavitation using a device of Mabel6 DUO Ultra Cavitation Technology system produced by DAEYANG MEDICAL COMPANY, KOREA will be applied on the abdominal region which extending bilaterally from the line extending from mid axilla to iliac crest, and above from center of diaphragm to the line extending between two iliac crest below. the session of Focused Ultra Sound will take 25- 30 minutes, twice/week and with about three day intervals for 12 weeks.

Also known as: cavitation

study group (Group A)

Low Caloric Diet (LCD) and a low (FODMAPs) diet BEHAVIORAL

The Low caloric diet (LCD) diet will be an equilibrated diet that had a caloric value 10% below the total metabolic expenditure (total energy expenditure) of each individual. The low FODMAPs diet (LFD) is a diet low in fermentable oligo-, di-, mono- saccharides and polyols (FODMAPs).

Also known as: dietary regimen

control group (Group B); study group (Group A)

aerobic exercise OTHER

aerobic exercise program under direct supervision at a frequency of 3 times/week for 12 weeks, in the form of walking on a treadmill for 30 minutes with moderate intensity (12-14) according to The Borg Rating of Perceived Exertion (RPE) scale.

control group (Group B); study group (Group A)

Eligibility Criteria

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

You may qualify if:

• All patients will be 20-45 years of age.
• Both genders will be participated.
• sedentary (exercise \< 2 times/week).
• Body mass index (BMI) will be ranged from 30 to 39.9 kg/m² and their waist circumference ≥ 102 cm for men and ≥ 88 cm for women.
• Patients will have the criteria of Irritable Bowel Syndrome (IBS) according to Rome IV Which are: recurrent abdominal pain on average at least one day per week during the previous three months associated with two or more of the following features must fulfill: (1) Pain is related to defecation; (2) Pain associated with a change in frequency of stool; and (3) Pain associated with a change in form or appearance of stool.
• mild to moderate Irritable Bowel Syndrome with score of 75- 300 according to the questionnaire of Irritable Bowel Syndrome Severity Scoring System (IBS-SSS).

You may not qualify if:

• Under 20 or above 45 years of age.
• Athletics
• Musculoskeletal, Carcinogenic, or kidney diseases, diabetes, hepatitis and cardiac disorders.
• Any condition that may prevent the use of the focused ultrasound on the abdominal region such as scarring, hernias or skin diseases in the abdominal area.
• Patients with severe Irritable Bowel Syndrome (IBS) or other known organic gastrointestinal disorders rather than IBS including: (1) Fever, Weight loss or Jaundice; (2) Change in the color of stool; (3) Signs of anemia or Thyroid disease; (4) Abdominal mass or Organomegaly; (5) Signs of intestinal obstruction.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

El-Sahel Teaching Hospital

Cairo, 11697, Egypt

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Obesity; Obesity, Abdominal

Interventions

Caloric Restriction; Diet; Exercise

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Aly S Elrashidy, M.Sc.

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aly S Elrashidy, M.Sc.

CONTACT

+201276755911; Alypek@yahoo.com

Heba A Abd Elghaffar Ali, PhD

CONTACT

+201005056590; hebaelshweety@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 30, 2023
• Study Start: May 28, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

EG (1)