InulinNCT06945302
The Effect of Inulin Supplementation in Individuals With IBS-C
A study testing Intervention Group in people with Inulin and IBS (Irritable Bowel Syndrome), run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inulin, IBS (Irritable Bowel Syndrome), Nutritional Status
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2021to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- a history of gastrointestinal surgery (except appendectomy and cholecystectomy)
- inflammatory bowel disease
- lactose malabsorption
- gastroenteritis
- celiac disease
- gastric
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Intervention Group, Control group (placebo)
- Keywords
- Anthropometric measurements, bowel symptoms, inulin, irritable bowel syndrome, nutritional status
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupDietary 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Dietary Supplement: Control group (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 week
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 8 weeks
Outcome Measure 4: Lean Body Mass
Description: "Lean body mass (kg) assessed using bioelectrical impedance analysis (Tanita BC 601)."
- Unit: kilograms
Measured: 8 weeks
Outcome Measure 5: Body Fat Percentage
Description: "Body fat percentage (%) assessed via bioelectrical impedance analysis (Tanita BC 601)."
- Unit: percentage (%)
Measured: 8 weeks
Outcome Measure 6: Total Body Water
Description: "Total body water percentage (%) assessed via bioelectrical impedance analysis (Tanita BC 601)."
- Unit: percentage (%)
Measured: 8 weeks
Outcome Measure 7: Bone Mass
Description: "Bone mass (kg) assessed using bioelectrical impedance analysis (Tanita BC 601)."
- Unit: kilograms
Measured: 8 weeks
Outcome Measure 8: BMI
Description: "Body mass index calculated from height and weight measurements (kg/m²)."
- Unit: kg/m²
Measured: 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.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start3 Nov 2021
- Primary completion3 Jan 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InulinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals were randomly assigned to one of two groups: Intervention (n=17) and control (n=17) groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağlar Akçalı, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945302
- Sponsor's protocol ID
- 2021-377
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
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 at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inulin Supplementation on Nutritional Status, Anthropometric Measurements and Bowel Symptoms in Individuals With IBS-C: RCT
- ClinicalTrials.gov ID
- NCT06945302
- Acronym / sponsor ID
- 2021-377
- Keywords
- Anthropometric measurements, bowel symptoms, inulin, irritable bowel syndrome, nutritional status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Individuals were randomly assigned to one of two groups: Intervention (n=17) and control (n=17) groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Intervention Groupproducts 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. |
| Control | Placebo comparator | 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 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- a history of gastrointestinal surgery (except appendectomy and cholecystectomy)
- inflammatory bowel disease
- lactose malabsorption
- gastroenteritis
- celiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Groupproducts 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 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. | Dietary supplement | Control |
Primary outcome
Irritable Bowel Syndrome - Symptom Severity Score/(IBS-SSS)
Time frame: 8 week
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.
9 secondary outcomes
Outcome Measure 1: Height Measurement
Time frame: 8 weeks
Outcome Measure 2: Waist Circumference
Time frame: 8 weeks
Outcome Measure 3: Hip Circumference
Time frame: 8 weeks
Outcome Measure 4: Lean Body Mass
Time frame: 8 weeks
Outcome Measure 5: Body Fat Percentage
Time frame: 8 weeks
Outcome Measure 6: Total Body Water
Time frame: 8 weeks
Outcome Measure 7: Bone Mass
Time frame: 8 weeks
Outcome Measure 8: BMI
Time frame: 8 weeks
Determination of Nutrient Consumption Status
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Results publicationMerdol, T.K. (2011). Standard meal schedules for institutions (4. edt). Ankara: Hatipoğlu Publishing.
- Results publicationRakıcıoğlu, N., Acar Tek, N., Ayaz, A., Pekcan, G. (2012). Food and nutrient photo catalog. Ankara: Hatiboğlu Publishing.
- Results publicationWorld Health Organization (WHO). (2011). Waist circumference and waist-hip ratio: report of a WHO expert consultation, Geneva, 8-11 December 2008.
- Results publicationBjelica, 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).
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Inulin and IBS (Irritable Bowel Syndrome), run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome - Symptom Severity Score/(IBS-SSS) (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06945302, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.