Effect of Polydextrose on Fecal Bulk and Bowel Function in Mildly Constipated Subjects

Study Overview
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Brief Summary
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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 colonic transit time have provided mixed results. The primary objective was to investigate the effect of PDX consumption by mildly constipated subjects on faecal bulk, measured as total faecal wet weight of 4-day collections. Secondary outcomes (faecal dry weight, defaecation frequency, stool consistency, ease of stool passage, total colonic transit time and gastrointestinal symptoms) were also explored. 51 subjects participated in a 4-week, two-center, randomized, double-blind, placebo-controlled, parallel study testing a control (CON) and a PDX treatment (18 g/d included in biscuits and drink mixtures)

Official Title
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A Two-center, Randomized, Double-blind, Placebo Controlled, Parallel Study to Evaluate the Effect of Polydextrose on Fecal Bulk and Bowel Function in Mildly Constipated Subjects

Conditions
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Constipation, Gastrointestinal Dysfunction

Intervention / Treatment
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* Dietary Supplement: Polydextrose
* Dietary Supplement: placebo-controlled


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, placebo-controlled, parallel study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Polydextrose (PDX)<br>Subject consumed a daily dose of 18g polydextrose enriched drink mixtures and biscuits (12 g from the drink mixtures and 6 g from the biscuits) providing 16.2 g dietary fibre/d. | Dietary Supplement: Polydextrose<br>* Polydextrose-enriched food products<br>|
| Placebo Comparator: Control (CON)<br>Subjects consumed placebo products, where maltodextrin replaced PDX and differed only in the amount of fibre per gram (1.7 g). | Dietary Supplement: placebo-controlled<br>* Control food products<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faecal bulk | Measured as total faecal wet weight | 4-day collections | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faecal dry weight | Measured as total faecal dry weight | 4-day collections during the intervention period | 
| Defaecation frequency | Recorded as defaecation frequency (i.e. number of stools) | 7-day period during the run-in period and intervention period | 
| Stool consistency | Measured using the Bristol Stool Form (BSF) score (1 = separate hard lumps, like nuts (difficult defaecation), 2 = sausage shaped but lumpy, 3 = like a sausage or snake but with cracks on its surface, 4 = like a sausage or snake, smooth and soft, 5 = soft blobs with clear cut edge, 6 = fluffy pieces with ragged edges, a mushy stool, 7 = watery, no solid pieces) | 7-day period during the run-in period and intervention period | 
| Ease of stool passage | Using a five-point scale (1 = very easy, 2 = easy, 3 = neither easy nor difficult, 4 = difficult, 5 = very difficult) | At the end of the intervention period | 
| Total colonic transit time | Using radio-opaque, barium sulfate impregnated polyethylene pellets located inside gelatin capsules | At the end of the intervention period for three consecutive days | 
| Gastrointestinal symptoms | Subjects ranked ranked the subjective tolerance variables daily to burping, cramping, distension/bloating, flatulence, nausea, reflux (heartburn) and vomiting on a four-point scale (1 = none, 2 = mild, 3 = moderate, 4 = severe) | Once at the end of the intervention period and during the previous one week (7 day-period). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polydextrose, mild constipation, faecal bulk, bowel function, clinical trial, fibre