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

Sponsor

Tate & Lyle (Industry)

Overall Status

Completed

CT.gov ID

NCT05309837

Collaborator

Oy Foodfiles Ltd (Other)

Enrollment

Arms

10.6

Actual Duration (Months)

Study Details

Study Description

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 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)

Condition or Disease	Intervention/Treatment	Phase
Constipation Gastrointestinal Dysfunction	Dietary Supplement: Polydextrose Dietary Supplement: placebo-controlled	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, double-blind, placebo-controlled, parallel study.Randomized, double-blind, placebo-controlled, parallel study.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

Sep 19, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Polydextrose (PDX) 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 Polydextrose-enriched food products
Placebo Comparator: Control (CON) 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 Control food products

Arm

Intervention/Treatment

Active Comparator: Polydextrose (PDX)

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

Polydextrose-enriched food products

Placebo Comparator: Control (CON)

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

Control food products

Outcome Measures

Primary Outcome Measures

Faecal bulk [4-day collections]
Measured as total faecal wet weight

Secondary Outcome Measures

Faecal dry weight [4-day collections during the intervention period]
Measured as total faecal dry weight
Defaecation frequency [7-day period during the run-in period and intervention period]
Recorded as defaecation frequency (i.e. number of stools)
Stool consistency [7-day period during the run-in period and intervention period]
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)
Ease of stool passage [At the end of the intervention period]
Using a five-point scale (1 = very easy, 2 = easy, 3 = neither easy nor difficult, 4 = difficult, 5 = very difficult)
Total colonic transit time [At the end of the intervention period for three consecutive days]
Using radio-opaque, barium sulfate impregnated polyethylene pellets located inside gelatin capsules
Gastrointestinal symptoms [Once at the end of the intervention period and during the previous one week (7 day-period).]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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