The Effect of Inulin Supplementation in Individuals With IBS-C

The Effect of Inulin Supplementation on Nutritional Status, Anthropometric Measurements and Bowel Symptoms in Individuals With IBS-C: RCT

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.

Study Overview

• Status: Completed
• Conditions: Nutritional Status; IBS (Irritable Bowel Syndrome); Inulin; Anthropometric Measurement
• Intervention / Treatment: Dietary supplement: Intervention Group; Dietary supplement: Control group (placebo)

Detailed Description

Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal disorder characterised by chronic abdominal pain, bloating, and altered bowel habits, often without identifiable organic pathology. IBS with predominant constipation (IBS-C) presents management challenges due to its multifactorial aetiology and impact on quality of life.

Inulin, a naturally occurring prebiotic dietary fibre found in many plants, has been studied for its beneficial effects on gut health, bowel function, and body composition. It may increase short-chain fatty acid production, improve intestinal transit, and promote beneficial gut microbiota such as Bifidobacteria. However, evidence on the specific benefits of inulin supplementation in individuals with IBS-C remains limited.

Inclusion criteria were being between the ages of 19-65 years, volunteering to participate in the study, being diagnosed with IBS by a physician according to Rome IV criteria, and having two of the three criteria according to Rome IV criteria: associated with defecation (alleviation), associated with change in defecation frequency, associated with change in stool appearance / symptoms started at least 6 months before the diagnosis was made and recurrent abdominal pain at least 1 day a week for the last 3 months. Exclusion criteria were a history of gastrointestinal surgery (except appendectomy and cholecystectomy), inflammatory bowel disease, lactose malabsorption, gastroenteritis, celiac disease, gastric and duodenal ulcer, metabolic diseases (cardiac, hepatic and renal diseases, diabetes, etc.), malignancy. ), history of malignancy, pregnancy and lactation, use of intestinal motility and 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, and use of prebiotic and probiotic supplements in the last 3 months.

In this study, eligible participants were randomly allocated into two groups:

• Intervention group (n=17): received 9.2 g/day of an inulin-oligofructose mixture (50:50), split into two doses daily.
• Control group (n=17): received an isocaloric placebo (maltodextrin, 9.2 g/day) using the same dosing schedule.

The intervention period was 8 weeks, during which participants continued their usual dietary habits. Assessments included dietary intake evaluations, anthropometric measurements (weight, BMI, waist and hip circumference, body composition via bioelectrical impedance), and IBS symptoms (using the IBS-SSS) at baseline and after 8 weeks.

The primary outcome was the change in IBS symptom severity (IBS-SSS scores). Secondary outcomes were changes in anthropometric parameters and dietary intake.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Mardin, Turkey, 47200
    • Mardin Artuklu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• use of prebiotic and probiotic supplements in the last 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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.
Placebo Comparator: Control; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcome Measure 1: Height Measurement	Description: "The height of the participants was measured using an inflexible tape measure with their head, hips, and heels touching the wall, and their feet standing side by side and in the Frankfort plane."; Unit: centimeters	8 weeks
Outcome Measure 2: Waist Circumference	Description: "The waist circumference was measured using a non-flexible tape measure with a sensitivity of 0.1 cm at the midpoint between the iliac crest and the lowest rib margin."; Unit: centimeters	8 weeks
Outcome Measure 3: Hip Circumference	Description: "Hip circumference was measured at the widest point of the hips using a non-flexible tape measure."; Unit: centimeters	8 weeks
Outcome Measure 4: Lean Body Mass	Description: "Lean body mass (kg) assessed using bioelectrical impedance analysis (Tanita BC 601)."; Unit: kilograms	8 weeks
Outcome Measure 5: Body Fat Percentage	Description: "Body fat percentage (%) assessed via bioelectrical impedance analysis (Tanita BC 601)."; Unit: percentage (%)	8 weeks
Outcome Measure 6: Total Body Water	Description: "Total body water percentage (%) assessed via bioelectrical impedance analysis (Tanita BC 601)."; Unit: percentage (%)	8 weeks
Outcome Measure 7: Bone Mass	Description: "Bone mass (kg) assessed using bioelectrical impedance analysis (Tanita BC 601)."; Unit: kilograms	8 weeks
Outcome Measure 8: BMI	Description: "Body mass index calculated from height and weight measurements (kg/m²)."; Unit: kg/m²	8 weeks
Determination of Nutrient Consumption Status	In order to determine the nutritional status of the participants, 24-hour food consumption records were taken at the beginning of the study and one-day food consumption records were taken in the 8th week. In determining the ingredients and quantities of some of the meals consumed, the book 'Standard Recipes' was used. The meals cooked at home were calculated by asking questions. 'Food and Nutrient Photo Catalogue' was used in order to evaluate the consumption measurements and quantities of foods accurately. The calculation of energy, macro and micronutrient values of the foods consumed was done with the Computer Assisted Nutrition (BEBIS) programme.	8 week

Collaborators and Investigators

• Sponsor: Mardin Artuklu University

Publications and helpful links

General Publications

• Merdol, T.K. (2011). Standard meal schedules for institutions (4. edt). Ankara: Hatipoğlu Publishing.
• Rakıcıoğlu, N., Acar Tek, N., Ayaz, A., Pekcan, G. (2012). Food and nutrient photo catalog. Ankara: Hatiboğlu Publishing.
• World Health Organization (WHO). (2011). Waist circumference and waist-hip ratio: report of a WHO expert consultation, Geneva, 8-11 December 2008.
• 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).

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): January 3, 2022
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: nutritional status; irritable bowel syndrome; bowel symptoms; inulin; Anthropometric measurements
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: 2021-377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to privacy concerns and ethical considerations related to the small sample size, which may increase the risk of participant identification

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No