The Effect of Inulin Supplementation in Individuals With IBS-C

NCT06945302 | Completed

• 1 other identifier: 2021-377
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Background: This study aimed to evaluate the effects of inulin supplementation on nutritional intake, anthropometric parameters, and bowel symptoms in individuals diagnosed with IBS-C. Method: This was a randomised, single-blind, placebo-controlled clinical trial. Participants were randomly allocated into intervention (inulin) and control (placebo) groups for 8 weeks. Assessments included dietary intake, anthropometric measurements, and IBS symptoms.

Conditions

Inulin; IBS (Irritable Bowel Syndrome); Nutritional Status; Anthropometric Measurement

Keywords

Anthropometric measurements; bowel symptoms; inulin; irritable bowel syndrome; nutritional status

Outcome Measures

Primary Outcomes (1)

• Irritable Bowel Syndrome - Symptom Severity Score/(IBS-SSS)

  The IBS-SSS scale was used to assess the severity of irritable bowel syndrome symptoms. This scale consists of a total of 5 questions, each of which is scored between 0 and 100. The questions provide information about the severity and frequency of abdominal pain, the severity of abdominal distension, the level of satisfaction with bowel habits and the impact of the disease on quality of life. An increase in the score obtained from the scale indicates an increase in symptom severity. ROC (Receiver Operating Characteristic) analysis was applied for the cut-off point of the scale. Accordingly, the cut-off point was calculated as 217.5.

  8 week

Secondary Outcomes (9)

• Outcome Measure 1: Height Measurement

  8 weeks

• Outcome Measure 2: Waist Circumference

  8 weeks

• Outcome Measure 3: Hip Circumference

  8 weeks

• Outcome Measure 4: Lean Body Mass

  8 weeks

• Outcome Measure 5: Body Fat Percentage

  8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

products containing a total of 9.2 g (4.6 g twice a day) inulin/oligofructose (50/50) mixture (prebiotic group) that individuals should consume daily were delivered to individuals in identical opaque bags.

Dietary Supplement: Intervention Group

Control

PLACEBO COMPARATOR

products containing a total of 9.2 g (4.6 g twice a day) maltodextrin (placebo group) that individuals should consume daily were delivered to individuals in identical opaque bags

Dietary Supplement: Control group (placebo)

Interventions

Intervention Group DIETARY_SUPPLEMENT

products containing a total of 9.2 g (4.6 g twice a day) inulin/oligofructose (50/50) mixture (prebiotic group) that individuals should consume daily were delivered to individuals in identical opaque bags.

Intervention group

Control group (placebo) DIETARY_SUPPLEMENT

products containing a total of 9.2 g (4.6 g twice a day) maltodextrin (placebo group) that individuals should consume daily were delivered to individuals in identical opaque bags.

Control

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the individuals were between 19-65 years of age
• volunteer to participate in the study
• Individuals diagnosed with IBS by a physician according to Rome IV criteria

You may not qualify if:

• a history of gastrointestinal surgery (except appendectomy and cholecystectomy)
• inflammatory bowel disease
• lactose malabsorption
• gastroenteritis
• celiac disease
• gastric
• duodenal ulcer
• metabolic diseases (cardiac, hepatic and renal diseases, diabetes, etc.)
• history of malignancy
• pregnancy and lactation
• use of intestinal motility
• antidepressant drugs
• involuntary body weight loss of more than 5 kg in the last 3 months
• use of dietary fibre supplements in the last 3 months
• use of antibiotics in the last 3 months

Sponsors & Collaborators

• Mardin Artuklu University: lead

Study Sites (1)

Mardin Artuklu University

Mardin, 47200, Turkey (Türkiye)

Location

Related Publications (4)

• Merdol, T.K. (2011). Standard meal schedules for institutions (4. edt). Ankara: Hatipoğlu Publishing.

  RESULT

• Rakıcıoğlu, N., Acar Tek, N., Ayaz, A., Pekcan, G. (2012). Food and nutrient photo catalog. Ankara: Hatiboğlu Publishing.

  RESULT

• World Health Organization (WHO). (2011). Waist circumference and waist-hip ratio: report of a WHO expert consultation, Geneva, 8-11 December 2008.

  RESULT

• Bjelica, D., Popović, S., Kezunović, M., Petković, J., Jurak, G., & Grasgruber, P. (2012). Body height and its estimation utilising arm span measurements in Montenegrin adults. Anthropological Notebooks, 18(2).

  RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Model Details: Individuals were randomly assigned to one of two groups: Intervention (n=17) and control (n=17) groups.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 25, 2025
• Study Start: November 3, 2021
• Primary Completion: January 3, 2022
• Study Completion: April 1, 2023
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)