Effect of sugar beet pectin on bowel habit and gut microbiota in healthy adults with hard stools: a randomized, double-blind, placebo controlled trial
- Conditions
- hard stools, tendency to constipation
- Registration Number
- DRKS00030572
- Lead Sponsor
- Cosun Beet Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Healthy subjects
- Hard stools defined by Bristol Stool Form Scale (category 1 to =2)
- Omnivore diet
- Age: 18 - 80 years
- All genders
- BMI (kg/m²): 18,5 - 34.9
- non-Smoker
- Subjects with stool consistency =3 (Bristol Stool Form Scale)
- Presence of acute/ chronic diseases
- Clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility, such as: coeliac disease, inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel disease diagnosed according to Rome III criteria with diarrhea-predominant type, irritable bowel syndrome diagnosed according to Rome IV criteria (highest level according to IBS-SSS), relevant bowel resections including short bowel syndrome
- Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements potentially interfering with this trial
- Regular intake of prebiotics or products claimed as prebiotic”, probiotic”, dietary fibres supplements and laxatives (medicinal drugs to promote intestinal transit) during the study
- Vegan, vegetarian diet
- Strongly atypical or restrictive diets/concepts followed voluntarily (macrobiotics, paleo diet, Atkins diet, Mayo diet, Insticto diet) or due to food intolerances/food allergies
- Average daily alcohol consumption > 10 g for women and > 20 g for men, consideration of alcohol abuse
- Athletes (extensive physical activity)
- Current use of antibiotics
- Willingness to discontinue laxatives approved as medicines
- Simultaneous participation in other studies that are associated with drug use and have a potentially significant impact on body composition or dietary behaviour
- Lactation, pregnancy, planned pregnancies that interfere with the study period
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Bristol Stool Form Scale (BSFS)
- Secondary Outcome Measures
Name Time Method - Number of bowel movements<br>- PAC-SYM (constipation-related symptom questionnaire, Likert-scale 0-4)<br>- PAC-QoL (constipation constipation-related quality of life questionnaire, Likert-scale 1-5)<br>- Gut microbiota composition