Back to resultsEffect of Polydextrose on Fecal Bulk and Bowel Function in Mildly Constipated Subjects
Primary Purpose
Constipation, Gastrointestinal Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Polydextrose
placebo-controlled
Sponsored by
About this trial
This is an interventional prevention trial for Constipation focused on measuring polydextrose, mild constipation, faecal bulk, bowel function, clinical trial, fibre
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Polydextrose (PDX)
Control (CON)
Arm Description
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.
Subjects consumed placebo products, where maltodextrin replaced PDX and differed only in the amount of fibre per gram (1.7 g).
Outcomes
Primary Outcome Measures
Faecal bulk
Measured as total faecal wet weight
Secondary Outcome Measures
Faecal dry weight
Measured as total faecal dry weight
Defaecation frequency
Recorded as defaecation frequency (i.e. number of stools)
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)
Ease of stool passage
Using a five-point scale (1 = very easy, 2 = easy, 3 = neither easy nor difficult, 4 = difficult, 5 = very difficult)
Total colonic transit time
Using radio-opaque, barium sulfate impregnated polyethylene pellets located inside gelatin capsules
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)
Full Information
NCT ID
NCT05309837
First Posted
March 25, 2022
Last Updated
April 1, 2022
Sponsor
Tate & Lyle
Collaborators
Oy Foodfiles Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05309837
Brief Title
Effect of Polydextrose on Fecal Bulk and Bowel Function in Mildly Constipated Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
September 19, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tate & Lyle
Collaborators
Oy Foodfiles Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Gastrointestinal Dysfunction
Keywords
polydextrose, mild constipation, faecal bulk, bowel function, clinical trial, fibre
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled, parallel study.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polydextrose (PDX)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control (CON)
Arm Type
Placebo Comparator
Arm Description
Subjects consumed placebo products, where maltodextrin replaced PDX and differed only in the amount of fibre per gram (1.7 g).
Intervention Type
Dietary Supplement
Intervention Name(s)
Polydextrose
Intervention Description
Polydextrose-enriched food products
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo-controlled
Intervention Description
Control food products
Primary Outcome Measure Information:
Title
Faecal bulk
Description
Measured as total faecal wet weight
Time Frame
4-day collections
Secondary Outcome Measure Information:
Title
Faecal dry weight
Description
Measured as total faecal dry weight
Time Frame
4-day collections during the intervention period
Title
Defaecation frequency
Description
Recorded as defaecation frequency (i.e. number of stools)
Time Frame
7-day period during the run-in period and intervention period
Title
Stool consistency
Description
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)
Time Frame
7-day period during the run-in period and intervention period
Title
Ease of stool passage
Description
Using a five-point scale (1 = very easy, 2 = easy, 3 = neither easy nor difficult, 4 = difficult, 5 = very difficult)
Time Frame
At the end of the intervention period
Title
Total colonic transit time
Description
Using radio-opaque, barium sulfate impregnated polyethylene pellets located inside gelatin capsules
Time Frame
At the end of the intervention period for three consecutive days
Title
Gastrointestinal symptoms
Description
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)
Time Frame
Once at the end of the intervention period and during the previous one week (7 day-period).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Essi Sarkkinen, PhD
Organizational Affiliation
Oy Foodfiles Ltd
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Polydextrose on Fecal Bulk and Bowel Function in Mildly Constipated Subjects
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