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

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

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)

Study Overview

• Status: Completed
• Conditions: Constipation; Gastrointestinal Dysfunction
• Intervention / Treatment: Dietary supplement: Polydextrose; Dietary supplement: placebo-controlled

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Mildly constipated healthy adults (who defecate 3- 5 days per week assessed by a 7-day bowel diary)
2. Provision of signed and dated informed consent prior to any study procedures
3. Body mass index (BMI) ≥ 19 and ≤ 29 kg/m2 at the screening visit
4. 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)
5. Use of adequate contraception in females of childbearing potential

Exclusion Criteria:

1. Regular use of laxatives
2. Use of medication which alters study subjects' gastrointestinal function (e.g. including but not exclusive neuroleptic medication, medication for Parkinson disease, opioids)
3. 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)
4. Type I and II diabetes
5. Previous major gastrointestinal surgery (e.g. intestinal resection, total gastrectomy, subtotal gastrectomy) or surgical treatment of obesity (within 6 months before the screening visit)
6. Present cancer (except basal cell skin cancer or squamous cell skin cancer, carcinoma in situ)
7. Untreated thyroid disease
8. History of stroke or myocardial infarction within six months prior the screening visit
9. Subjects who were actively dieting for weight loss, or had eating disorders (anorexia, bulimia)
10. Lack of compliance to the study procedures
11. Females who were pregnant or breast-feeding or planning pregnancy
12. 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),
13. Allergy/hypersensitivity/intolerance to study products
14. Vegetarians or regularly consuming fibre supplements/fibre supplemented foods
15. Any clinically significant disease/condition which in the Investigator's opinion could interfere with the results of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Tate & Lyle
• Collaborators: Oy Foodfiles Ltd
• Investigators: Study Director: Essi Sarkkinen, PhD, Oy Foodfiles Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): September 19, 2013

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: clinical trial; bowel function; fibre; polydextrose; mild constipation; faecal bulk
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: TALI "4010"

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No