ConstipationNCT05309837
Effect of Polydextrose on Fecal Bulk and Bowel Function in Mildly Constipated Subjects
A study testing Polydextrose in people with Constipation and Gastrointestinal Dysfunction, run by Tate & Lyle.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Gastrointestinal Dysfunction
- What is being tested?
- Polydextrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to 19 Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
About this study
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
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
- Being tested
- Polydextrose, placebo-controlled
- Keywords
- polydextrose, mild constipation, faecal bulk, bowel function, clinical trial, fibre
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolydextroseDietary supplement
Polydextrose-enriched food products
placebo-controlledDietary supplement
Control food products
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Dietary Supplement: placebo-controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faecal bulk
Measured as total faecal wet weight
Measured: 4-day collections
Secondary outcomes (6)
Faecal dry weight
Measured as total faecal dry weight
Measured: 4-day collections during the intervention period
Defaecation frequency
Recorded as defaecation frequency (i.e. number of stools)
Measured: 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)
Measured: 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)
Measured: At the end of the intervention period
Total colonic transit time
Using radio-opaque, barium sulfate impregnated polyethylene pellets located inside gelatin capsules
Measured: 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)
Measured: Once at the end of the intervention period and during the previous one week (7 day-period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study startNov 2012
- Primary completionMay 2013
- Study completion19 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tate & Lyle
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oy Foodfiles Ltd
- Responsible party
- Sponsor
- Investigators
- Essi Sarkkinen, PhD, Study director, Oy Foodfiles Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309837
- Sponsor's protocol ID
- TALI "4010"
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05309837
- Acronym / sponsor ID
- TALI "4010"
- Conditions
- Constipation, Gastrointestinal Dysfunction
- Keywords
- polydextrose, mild constipation, faecal bulk, bowel function, clinical trial, fibre
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Tate & LyleIndustry (pharma, biotech, devices)
- Collaborators
- Oy Foodfiles Ltd
- Study start
- Nov 2012 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- 19 Sep 2013 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel study.
| Arm | Type | Receives |
|---|---|---|
| Polydextrose (PDX) | Active comparator | Dietary Supplement: PolydextroseSubject 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. |
| Control (CON) | Placebo comparator | Dietary Supplement: placebo-controlledSubjects consumed placebo products, where maltodextrin replaced PDX and differed only in the amount of fibre per gram (1.7 g). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolydextrosePolydextrose-enriched food products | Dietary supplement | Polydextrose (PDX) |
| placebo-controlledControl food products | Dietary supplement | Control (CON) |
Primary outcome
Faecal bulk
Time frame: 4-day collections
Measured as total faecal wet weight
6 secondary outcomes
Faecal dry weight
Time frame: 4-day collections during the intervention period
Defaecation frequency
Time frame: 7-day period during the run-in period and intervention period
Stool consistency
Time frame: 7-day period during the run-in period and intervention period
Ease of stool passage
Time frame: At the end of the intervention period
Total colonic transit time
Time frame: At the end of the intervention period for three consecutive days
Gastrointestinal symptoms
Time frame: Once at the end of the intervention period and during the previous one week (7 day-period).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Essi Sarkkinen, PhD study director
Oy Foodfiles Ltd
Questions about this trial
What is this clinical trial studying?
A study testing Polydextrose in people with Constipation and Gastrointestinal Dysfunction, run by Tate & Lyle.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faecal bulk (time frame: 4-day collections). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.