Evaluating the Effects of Low FODMAP and Gluten-Free Diet on Nutritional Status, Quality of Life, and Gastrointestinal Symptoms in Irritable Bowel Syndrome (IBS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Food consumption records
研究概览
简要总结
The data of the research will be collected from patients who have applied to the Gastroenterology Polyclinic of Kayseri City Hospital or have previously been diagnosed with Irritable Bowel Syndrome (IBS). The data will be collected through face-to-face interviews using a questionnaire form. Participation in the study is entirely voluntary, and participants have the right to withdraw from the research at any time if they wish.
The general flowchart of the research is shown in Figure 1.
Figure 1. Flowchart of the Research
Patients with IBS applying to the Gastroenterology Polyclinic:
According to Rome IV criteria, individuals aged between 19-64, with BMI >18.5 and <29.9 kg/m2, non-cancerous, not using probiotics in the last month, and not following a gluten-free diet.
Interview Group 1: Low FODMAP diet Group 2: Gluten-free diet
Socio-demographic characteristics, general dietary habits, level of physical activity, anthropometric measurements, body composition analysis, IBS-SSS, IBS-QOL, IBS-VAS, Bristol Stool Scale, 24-hour retrospective food consumption record, Food Frequency Questionnaire.
Second Interview (after 4 weeks)
Anthropometric measurements, body composition analysis, IBS-SSS, IBS-QOL, IBS-VAS, Bristol Stool Scale, 3-day retrospective food consumption record.
详细描述
Survey Form The survey form administered to all participants in the study will include sociodemographic characteristics, information on general dietary habits (19 questions), physical activity (2 questions), and diagnostic information related to the disease (9 questions). Information on additional methods participants resort to alleviate their IBS symptoms (alternative treatments and dietary supplements such as fiber, prebiotics, probiotics, aloe vera, peppermint oil) will also be included in the survey.
Anthropometric Measurements Anthropometric measurements and body composition of the participants will be determined by the researcher after the diagnosis of IBS and before initiating any dietary intervention, as well as after a 4-week dietary intervention.
Body weight: The participants' body weight will be measured using the TANITA MC-780 model with minimal clothing and without shoes.
Height: Height measurement will be taken while the feet are together and the head is in the Frankfort plane (ear canal and bottom of the eye socket aligned horizontally, with the gaze parallel to the ground).
Body mass index (BMI): BMI will be calculated by dividing body weight in kilograms by the square of height in meters. BMI will be evaluated according to the classification provided by the World Health Organization (WHO). According to this classification, individuals with BMI <18.5 kg/m² are considered "underweight," those with BMI 18.5-24.9 kg/m² are considered "normal," individuals with BMI 25.0-29.9 kg/m² are classified as "overweight," those with BMI 30.0-34.9 kg/m² are considered "obese class 2," and those with BMI >40 kg/m² are considered "obese class 3." Waist circumference: Waist circumference will be measured using a non-stretchable tape measure at the midpoint between the lower rib and the iliac crest. Waist circumference will be evaluated according to the WHO classification, considering waist circumference greater than 102 cm in men and greater than 88 cm in women as high risk for metabolic complications.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants between the ages of 18-65 who have been diagnosed with Irritable Bowel Syndrome (IBS) according to the Rome IV criteria,
- •who are capable of making food choices independently,
- •who do not have perception disorders or communication problems
排除标准
- •Patients with inflammatory bowel disease
- •celiac disease
- •known lactose intolerance
- •advanced cardiac, respiratory, renal, or hepatic diseases
- •malignancy
- •major psychiatric disorders, or a history of drug/alcohol abuse
- •Patients with a history of previous abdominal surgery other than uncomplicated appendicitis
- •pregnant and lactating patients
研究组 & 干预措施
Gluten free diet group
Gluten-free diet therapy was implemented for 1 month
干预措施: Diet therapy (Behavioral)
LOW FODMAP diet group
Low FODMAP diet therapy was implemented for 1 month
干预措施: Diet therapy (Behavioral)
结局指标
主要结局
Food consumption records
时间窗: "To observe the effect of low FODMAP diet therapy on IBS quality of life after 1 month."
The low FODMAP diet involves the elimination of foods rich in fermentable oligo-, di-, monosaccharides and polyols, fructans, galactooligosaccharides (such as rye, barley, wheat, onions, and legumes), lactose-containing products (milk, yogurt, cheese), excessive fructose (apples, pears, watermelon, asparagus, honey), and foods rich in sorbitol, mannitol, and xylitol. It consists of a list indicating permitted and forbidden foods according to food groups. General recommendations are provided at the end of the diet list.
Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
时间窗: To observe the effect of diet therapy on GIS sypmtoms of life after 1 month."
Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) will be used at the beginning and end of the study to assess the severity of symptoms of irritable bowel syndrome. To calculate symptom scores, participants will be asked 4 questions on a scale of 0 to 100. Based on the calculated score, the severity of the disease will be classified as follows: (0-74) for remission, (75-174) for mild, (175-299) for moderate, and (\>300) for severe.
Quality of Life Scale in Irritable Bowel Syndrome Patients (IBS-QOL)
时间窗: To observe the effect of diet therapy on Quality of Life Scale of life after 1 month."
The Irritable Bowel Syndrome Quality of Life Scale (IBS-QOL) will be applied at the beginning and end of the study to evaluate the level of quality of life of patients with irritable bowel syndrome. This questionnaire, designed for patients with irritable bowel syndrome, evaluates disease symptoms as well as the psychological, sociological effects of the disease, and its impact on individuals' sexual lives, among other topics. The questionnaire consists of 8 sub-scales, with 34 questions, allowing for the evaluation of quality of life on a scale of 100 points.
Food consumption records
时间窗: To observe the effect of gluten free diet therapy on IBS quality of life after 1 month
The gluten-free diet is created by eliminating gluten-containing foods (such as wheat, barley, rye, etc.) from the diet. Permitted and forbidden foods are listed according to food groups, with general recommendations added at the end of the diet list. Participants will be provided with separate lists of permitted and forbidden foods for the low FODMAP diet and the gluten-free diet, along with general recommendations, and the diets will be explained to them. There will be no additional energy calculation or modified diet used in our study.
次要结局
未报告次要终点
研究者
Aslı Gizem Çapar
asst.prof.
Nuh Naci Yazgan University