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

NCT05309837 | Completed

• 1 other identifier: TALI "4010"
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Constipation; Gastrointestinal Dysfunction

Keywords

polydextrose; mild constipation; faecal bulk; bowel function; clinical trial; fibre

Outcome Measures

Primary Outcomes (1)

• Faecal bulk

  Measured as total faecal wet weight

  4-day collections

Secondary Outcomes (6)

• Faecal dry weight

  4-day collections during the intervention period

• Defaecation frequency

  7-day period during the run-in period and intervention period

• Stool consistency

  7-day period during the run-in period and intervention period

• Ease of stool passage

  At the end of the intervention period

• Total colonic transit time

  At the end of the intervention period for three consecutive days

Study Arms (2)

Polydextrose (PDX)

ACTIVE COMPARATOR

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

Control (CON)

PLACEBO COMPARATOR

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

Interventions

Polydextrose DIETARY_SUPPLEMENT

Polydextrose-enriched food products

Polydextrose (PDX)

placebo-controlled DIETARY_SUPPLEMENT

Control food products

Control (CON)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tate & Lyle: lead
• Oy Foodfiles Ltd: collaborator

MeSH Terms

Conditions

Constipation

Interventions

polydextrose

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Essi Sarkkinen, PhD

  Oy Foodfiles Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel study.

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: September 19, 2013
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share