The Effect of Inulin Supplementation on Nutritional Status, Anthropometric Measurements and Bowel Symptoms in Individuals With IBS-C: RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Irritable Bowel Syndrome - Symptom Severity Score/(IBS-SSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants were blinded to groups
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •a history of gastrointestinal surgery (except appendectomy and cholecystectomy)
- •inflammatory bowel disease
- •lactose malabsorption
- •gastroenteritis
- •celiac disease
- •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.
结局指标
主要结局
Irritable Bowel Syndrome - Symptom Severity Score/(IBS-SSS)
时间窗: 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.
次要结局
- Outcome Measure 7: Bone Mass(8 weeks)
- Outcome Measure 8: BMI(8 weeks)
- 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)
- Outcome Measure 6: Total Body Water(8 weeks)
- Determination of Nutrient Consumption Status(8 week)
研究者
Çağlar Akçalı
Assist. Prof.
Mardin Artuklu University