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

NCT ID: NCT05309837

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-09-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Polydextrose

Intervention Type: DIETARY_SUPPLEMENT

Polydextrose-enriched food products

Control (CON)

Subjects consumed placebo products, where maltodextrin replaced PDX and differed only in the amount of fibre per gram (1.7 g).

Group Type: PLACEBO_COMPARATOR

placebo-controlled

Intervention Type: DIETARY_SUPPLEMENT

Control food products

Interventions

Polydextrose

Polydextrose-enriched food products

Intervention Type: DIETARY_SUPPLEMENT

placebo-controlled

Control food products

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oy Foodfiles Ltd

OTHER

Sponsor Role: collaborator

Tate & Lyle

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Essi Sarkkinen, PhD

Role: STUDY_DIRECTOR

Oy Foodfiles Ltd

Other Identifiers

TALI "4010"

Identifier Type: -

Identifier Source: org_study_id