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

Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05309837
• Other study ID #: TALI "4010"
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: September 19, 2013

Study information

• Verified date: March 2022
• Source: Tate & Lyle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 19, 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Gastrointestinal Dysfunction

Intervention

Dietary Supplement:
• Polydextrose
Polydextrose-enriched food products
• placebo-controlled
Control food products

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tate & Lyle	Oy Foodfiles Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Faecal bulk	Measured as total faecal wet weight	4-day collections
Secondary	Faecal dry weight	Measured as total faecal dry weight	4-day collections during the intervention period
Secondary	Defaecation frequency	Recorded as defaecation frequency (i.e. number of stools)	7-day period during the run-in period and intervention period
Secondary	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
Secondary	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
Secondary	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
Secondary	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).