Clinical trial NCT06945302: The Effect of Inulin Supplementation in Individuals With IBS-C
Official title: The Effect of Inulin Supplementation on Nutritional Status, Anthropometric Measurements and Bowel Symptoms in Individuals With IBS-C: RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inulin
IBS (Irritable Bowel Syndrome)
Nutritional Status
Anthropometric Measurement
Keywords: Anthropometric measurements
bowel symptoms
inulin
irritable bowel syndrome
nutritional status
Lead sponsor: Mardin Artuklu University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals were randomly assigned to one of two groups: Intervention (n=17) and control (n=17) groups.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Irritable Bowel Syndrome - Symptom Severity Score/(IBS-SSS)
timeFrame: 8 week
Secondary outcomes:
measure: Outcome Measure 1: Height Measurement
timeFrame: 8 weeks
measure: Outcome Measure 2: Waist Circumference
timeFrame: 8 weeks
measure: Outcome Measure 3: Hip Circumference
timeFrame: 8 weeks
measure: Outcome Measure 4: Lean Body Mass
timeFrame: 8 weeks
measure: Outcome Measure 5: Body Fat Percentage
timeFrame: 8 weeks
measure: Outcome Measure 6: Total Body Water
timeFrame: 8 weeks
measure: Outcome Measure 7: Bone Mass
timeFrame: 8 weeks
measure: Outcome Measure 8: BMI
timeFrame: 8 weeks
measure: Determination of Nutrient Consumption Status
timeFrame: 8 week
Other outcomes:
Locations:
city: Mardin
country: Turkey
facility: Mardin Artuklu University
Study officials:
References:
citation: Merdol, T.K. (2011). Standard meal schedules for institutions (4. edt). Ankara: Hatipoğlu Publishing.
citation: Rakıcıoğlu, N., Acar Tek, N., Ayaz, A., Pekcan, G. (2012). Food and nutrient photo catalog. Ankara: Hatiboğlu Publishing.
citation: World Health Organization (WHO). (2011). Waist circumference and waist-hip ratio: report of a WHO expert consultation, Geneva, 8-11 December 2008.
citation: 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).