Skip to main content
OpenTrials
Completed

NCT Number: NCT05584254

Effects of β-glucans on Gut Permeability and Microbiota in Elderly

The investigators aim was to compare healthy young adults, senior orienteers (model of healthy ageing) and elderly with gastrointestinal symptoms on intestinal permeability, microbiota compositions and well-being. In addition, assess whether 3 weeks of oral intake of soluble or dispersible forms yeast-dervied beta-glucan could improve intestinal barrier function against drug-induced barrier disruption vs placebo for a cohort of elderly people with gastrointestinal symptoms, in a randomized double blinded placebo-controlled cross-over clinical trial.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Elderly Bowel Symptoms Prebiotics

Age range

55 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus USÖ, Örebro University

Örebro, 70362, Sweden

About this study

Baseline samples for measurements of intestinal permeability (multisugar test), microbiota composition (faecal samples) and well-being (questionnaires) were collected during the first week for:

Young healthy adults (healthy young controls) Senior orienteers (healthy elderly controls) Elderly with gastrointestinal (GI) symptoms

Thereafter only the elderly with GI symptoms continued into the randomized cross-over trial where they were blindly and randomly distributed one of the following: Soluble yeast-derived beta-glucan, dispersible (whole) yeast-derived beta-glucan and placebo. Each supplement was taken for 3 weeks with a 1 week washout until all participants had taken all supplements. Towards the end of each supplement period, samples for measurement of intestinal permeability and microbiota were collected, in addition to questionnaires being filled out.

Who can participate

Healthy volunteers accepted: Yes

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

Elderly with gastrointestinal symptoms

Inclusion criteria

  • Informed consent signed by study participant
  • Age >55 years
  • Scoring above 2 on the dimensions for diarrhoea and constipation on the Gastrointestinal symptoms rating scale (GSRS)
  • Mentally and physically fit to complete questionnaires during the study period

Exclusion criteria

  • Known or genic gastrointestinal diseasewith strictures, malignance's and ischemia.
  • Inflammatory bowel diseases (IBD)
  • Participation in other clinical trials in the past three months.
  • Intake of medications know to change the inflammatory status (i.e proton pump inhibitors, antibiotic, anti-inflammtory medication (including NSAIDs)

Healthy controls

Inclusion criteria

  • Age ≥ 18 years
  • Informed consent signed by the study participant
  • Mentally and physically fit to complete questionnaires during the study period

Exclusion criteria

  • Previous abdominal surgery
  • A hypertonic condition demanding medical treatment
  • Diagnosed psychiatric disease
  • Lactose intolerance
  • Usage of medical prescribed medications, expect oral contraceptives, during the 14 days preceding study start
  • Premenstrual syndrome
  • Pregnant or breast feeding
  • Known or genic gastrointestinal disease, with strictures, malignance's and ischemia.
  • Inflammatory bowel diseases (IBD)
  • Participation in other clinical trials in the past three months.

Treatment and study plan

yeast-beta glucan

Dietary Supplement

Primary outcomes

  1. Intestinal permeability at baseline (before indomethacin)

    Time frame: Day 1

    In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.

  2. Intestinal permeability at baseline (after indomethacin)

    Time frame: Day 1

    In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.

  3. Changes in Intestinal permeability 3 weeks after study supplementation 1 (before indomethacin).

    Time frame: 3 weeks

    Performed after study participants have orally taken study supplementation 1 for 3 weeks. In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.

  4. Changes in intestinal permeability 3 weeks after study supplementation 1 (after indomethacin).

    Time frame: 3 weeks

    Performed after study participants have orally taken study supplementation 1 for 3 weeks.

    In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.

  5. Changes in intestinal permeability 3 weeks after study supplementation 2 (before indomethacin)

    Time frame: 3 weeks

    Performed after study participants have orally taken study supplementation 2 for 3 weeks.

    In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.

  6. Changes in intestinal permeability 3 weeks after study supplementation 2 (after indomethacin)

    Time frame: 3 weeks

    Performed after study participants have orally taken study supplementation 2 for 3 weeks.

    In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.

  7. Changes in intestinal permeability 3 weeks after study supplementation 3 (before indomethacin)

    Time frame: 3 weeks

    Performed after study participants have orally taken study supplementation 3 for 3 weeks.

    In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.

  8. Changes in intestinal permeability 3 weeks after study supplementation 3 (after indomethacin)

    Time frame: 3 weeks

    Performed after study participants have orally taken study supplementation 3 for 3 weeks.

    In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.

Secondary outcomes

  1. Microbiota diversity - at baseline

    Time frame: Day 1

    Faecal samples will be used for next-generation sequencing and analysed for diversity

  2. Bacterial species - at baseline

    Time frame: Day 1

    Faecal samples will be used for next-generation sequencing and analysed for bacterial species

  3. Changes in microbiota diversity 3 weeks after study supplementation 1

    Time frame: 3 weeks

    Faecal samples will be used for next-generation sequencing and analysed for changes in microbiota diversity

  4. Changes in bacterial species 3 weeks after study supplementation 1

    Time frame: 3 weeks

    Faecal samples will be used for next-generation sequencing and analysed for changes in bacterial species levels

  5. Changes in microbiota diversity 3 weeks after study supplementation 2

    Time frame: 3 weeks

    Faecal samples will be used for next-generation sequencing and analysed for changes in microbiota diversity

  6. Changes in bacterial species 3 weeks after study supplementation 2

    Time frame: 3 weeks

    Faecal samples will be used for next-generation sequencing and analysed for changes in bacterial species levels

  7. Changes in microbiota diversity 3 weeks after study supplementation 3

    Time frame: 3 weeks

    Faecal samples will be used for next-generation sequencing and analysed for changes in microbiota diversity

  8. Changes in bacterial species 3 weeks after study supplementation 3

    Time frame: 3 weeks

    Faecal samples will be used for next-generation sequencing and analysed for changes in bacterial species levels

  9. Changes in microbiota diversity - Washout (1 week after ending supplementation 1, i.e. 4 weeks after baseline)

    Time frame: 4 weeks

    Faecal samples will be used for next-generation sequencing and analysed for changes in microbiota diversity from 1 weeks washout, after ending study supplementation 1 (4 weeks after baseline)

  10. Changes in bacterial species - Washout (1 week after ending study supplementation 1, i.e. 4 weeks after baseline)

    Time frame: 4 weeks

    Faecal samples will be used for next-generation sequencing and analysed for changes in bacterial species from 1 weeks washout, after ending study supplementation 1 (4 weeks after baseline)

  11. Changes in microbiota diversity - Washout (1 week after ending study supplementation 2, i.e. 4 weeks after baseline)

    Time frame: 4 weeks

    Faecal samples will be used for next-generation sequencing and analysed for changes in microbiota diversity from 1 weeks washout, after ending study supplementation 2 (4 weeks after baseline)

  12. Changes in bacterial species - Washout (1 week after ending study supplementation 2, i.e. 4 weeks after baseline)

    Time frame: 4 weeks

    Faecal samples will be used for next-generation sequencing and analysed for changes in bacterial species from 1 weeks washout, after ending study supplementation 2 (4 weeks after baseline).

  13. Changes in microbiota diversity - Washout (1 week after ending study supplementation 3, i.e. 4 weeks after baseline)

    Time frame: 4 weeks

    Faecal samples will be used for next-generation sequencing and analysed for changes in microbiota diversity from 1 weeks washout, after ending study supplementation 3 (4 weeks after baseline)

  14. Changes in bacterial species - Washout (1 week after ending study supplementation 3, i.e. 4 weeks after baseline)

    Time frame: 4 weeks

    Faecal samples will be used for next-generation sequencing and analysed for changes in bacterial species from 1 weeks washout, after ending study supplementation 3 (4 weeks after baseline)

  15. Changes in gastrointestinal symptom questionnaire scores

    Time frame: up to 13 weeks

    The Gastrointestinal Symptoms Rating Scale (GSRS) evaluates gastrointestinal (GI) symptoms based on the 5 domains diarrhoea, constipation, reflux, indigestion and abdominal pain. The symptoms are assessed with 15 items, ranging in scores 1 to 7 depending on their severity. A score of 1 represents "no problems" and score 7 represents "severe problems". The severity of symptoms may be defined as no problems (1 point), mild (1-2 points), moderate (2-4 points), and severe (4-7 points). The scores for each domain was calculated as the mean score of each corresponding item while the mean total GSRS score reflects the general severity of GI symptoms.

  16. Changes in hospital and anxiety depression scores

    Time frame: up to 13 weeks

    The Hospital Anxiety and Depression Scale (HADS) was used to evaluate the psychological distress of study participants.This questionnaire consists of 14 items subdivided in two subscales for the assessment of anxiety or depression. The total score is used as a measure of general psychological distress. The minimum score is 0 and the maximum score is 21. A score > 8 on respective subscales indicates a significant level of anxiety or depression.

  17. Changes in perceived stress scale scores

    Time frame: Up to 13 weeks

    The perceived stress scale (PSS) consists of 10 items, including a number of direct questions about current levels of experienced stress. The respondent answers how often a certain emotion has been present during the past month. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Each item is rated on a 5-point scale ranging from never (0) to almost always (4). The questions in this scale ask about the responders feelings and thoughts during the last month. In each case the questionnaire requires the respondent to indicate by circling how often they felt or thought a certain way.

  18. Changes in quality of life questionnaire scores

    Time frame: Up to 13 weeks

    The EuroQol 5D-5L (EQ-5D-5L) tool consists of two parts; 5Q-5D, which includes 5 items related to wellbeing and function (mobility, self-care, usual activities, pain/discomfort and anxiety/ depression) and the visual analogue scale, 5Q-5D-VAS, ranging from 0 to 100.

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • Kerry Group

Registry information

Official study title

Effects of β-glucan Based Dietary Fibres on Indomethacin-induced Hyperpermeability and Gut Microbiota Composition in Elderly: A Randomized Placebo-controlled Crossover Clinical Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 18, 2022
Registry last updated
Mar 23, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.