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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06945302
Enrollment
34
Registered
2025-04-25
Start date
2021-11-03
Completion date
2023-04-01
Last updated
2025-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTIntervention 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_SUPPLEMENTControl 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.

Sponsors

Mardin Artuklu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants were blinded to groups

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Irritable Bowel Syndrome - Symptom Severity Score/(IBS-SSS)8 weekThe 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.

Secondary

MeasureTime frameDescription
Outcome Measure 2: Waist Circumference8 weeksDescription: 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
Outcome Measure 3: Hip Circumference8 weeksDescription: Hip circumference was measured at the widest point of the hips using a non-flexible tape measure. * Unit: centimeters
Outcome Measure 4: Lean Body Mass8 weeksDescription: Lean body mass (kg) assessed using bioelectrical impedance analysis (Tanita BC 601). * Unit: kilograms
Outcome Measure 5: Body Fat Percentage8 weeksDescription: Body fat percentage (%) assessed via bioelectrical impedance analysis (Tanita BC 601). * Unit: percentage (%)
Outcome Measure 1: Height Measurement8 weeksDescription: 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
Outcome Measure 7: Bone Mass8 weeksDescription: Bone mass (kg) assessed using bioelectrical impedance analysis (Tanita BC 601). * Unit: kilograms
Outcome Measure 8: BMI8 weeksDescription: Body mass index calculated from height and weight measurements (kg/m²). * Unit: kg/m²
Determination of Nutrient Consumption Status8 weekIn 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.
Outcome Measure 6: Total Body Water8 weeksDescription: Total body water percentage (%) assessed via bioelectrical impedance analysis (Tanita BC 601). * Unit: percentage (%)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026