Status:
COMPLETED
Effect of Polydextrose on Fecal Bulk and Bowel Function in Mildly Constipated Subjects
Lead Sponsor:
Tate & Lyle
Collaborating Sponsors:
Oy Foodfiles Ltd
Conditions:
Constipation
Gastrointestinal Dysfunction
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Polydextrose (PDX) (8-30g/day) has been reported to increase faecal bulk and consistency, leading to easier stool passage in healthy subjects. Studies on its effect on defaecation frequency and coloni...
Eligibility Criteria
Inclusion
- Mildly constipated healthy adults (who defecate 3- 5 days per week assessed by a 7-day bowel diary)
- Provision of signed and dated informed consent prior to any study procedures
- Body mass index (BMI) ≥ 19 and ≤ 29 kg/m2 at the screening visit
- Total score on fibre intake questionnaire max 17 points for women and 20 points for men (where each point represents approximately 1 g fibre intake)
- Use of adequate contraception in females of childbearing potential
Exclusion
- Regular use of laxatives
- Use of medication which alters study subjects' gastrointestinal function (e.g. including but not exclusive neuroleptic medication, medication for Parkinson disease, opioids)
- History of digestive disease (e.g. celiac disease, Crohn's disease, ulcerative colitis, gastrointestinal malignancy, fistula of intestine, ischemic colitis, bile acid malabsorption, repeated diverticulitis)
- Type I and II diabetes
- Previous major gastrointestinal surgery (e.g. intestinal resection, total gastrectomy, subtotal gastrectomy) or surgical treatment of obesity (within 6 months before the screening visit)
- Present cancer (except basal cell skin cancer or squamous cell skin cancer, carcinoma in situ)
- Untreated thyroid disease
- History of stroke or myocardial infarction within six months prior the screening visit
- Subjects who were actively dieting for weight loss, or had eating disorders (anorexia, bulimia)
- Lack of compliance to the study procedures
- Females who were pregnant or breast-feeding or planning pregnancy
- Known or suspected abuse of alcohol (more than 14 units of alcohol per week, one unit = 4 cl spirit, 12 cl wine or 33 cl medium strong beer / cider),
- Allergy/hypersensitivity/intolerance to study products
- Vegetarians or regularly consuming fibre supplements/fibre supplemented foods
- Any clinically significant disease/condition which in the Investigator's opinion could interfere with the results of the study
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2013
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT05309837
Start Date
November 1 2012
End Date
September 19 2013
Last Update
April 4 2022
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