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NCT Number: NCT05309837

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)

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Key information

Conditions

Constipation Gastrointestinal Dysfunction Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polydextrose

Dietary Supplement

Polydextrose-enriched food products

placebo-controlled

Dietary Supplement

Control food products

Primary outcomes

  1. Faecal bulk

    Time frame: 4-day collections

    Measured as total faecal wet weight

Secondary outcomes

  1. Faecal dry weight

    Time frame: 4-day collections during the intervention period

    Measured as total faecal dry weight

  2. Defaecation frequency

    Time frame: 7-day period during the run-in period and intervention period

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

  3. Stool consistency

    Time frame: 7-day period during the run-in period and intervention period

    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)

  4. Ease of stool passage

    Time frame: At the end of the intervention period

    Using a five-point scale (1 = very easy, 2 = easy, 3 = neither easy nor difficult, 4 = difficult, 5 = very difficult)

  5. Total colonic transit time

    Time frame: At the end of the intervention period for three consecutive days

    Using radio-opaque, barium sulfate impregnated polyethylene pellets located inside gelatin capsules

  6. Gastrointestinal symptoms

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

    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)

Sponsors and collaborators

Lead sponsor

Tate & Lyle

Industry

Collaborators

  • Oy Foodfiles Ltd

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2022
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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