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

Tate & Lyle51 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Constipation Gastrointestinal Dysfunction

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Faecal bulk

Measured as total faecal wet weight

Time frame: 4-day collections

Secondary Outcomes

Faecal dry weight

Measured as total faecal dry weight

Time frame: 4-day collections during the intervention period

Defaecation frequency

Recorded as defaecation frequency (i.e. number of stools)

Time frame: 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)

Time frame: 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)

Time frame: At the end of the intervention period

Total colonic transit time

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

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)

Time frame: Once at the end of the intervention period and during the previous one week (7 day-period).