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Completed

NCT Number: NCT03336385

Prebiotic Supplementation and Intestinal Barrier Function in Elderly: a RCT

The investigators aim was to assess whether 6 weeks of oral intake of the wheat-derived prebiotic fiber arabinoxylan or oat-derived beta-glucan could improve intestinal barrier function against drug-induced barrier disruption in a general population of elderly people, in a randomized double blinded placebo-controlled clinical trial.

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Key information

Conditions

Prebiotics Aged

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro University

Örebro, 701 82, Sweden

About this study

The study consisted of a 9 week clinical trial to which the study participants orally ingested two different prebiotic compounds/one placebo for a total of 6 weeks.

The primary outcome was intestinal permeability which was measured before/after indomethacin intake before starting with the prebiotic supplementation and repeated 6 weeks afterwards.

Indomethacin is an NSAID known to artificially increase the intestinal permeability. The prebiotic fibers arabinoxylan and oat-derived beta-glucan have not been investigated for their effect on intestinal permeability in older adults.

Intestinal permeability was investigated using the multi-sugar permeability test. Participants ingested a water solution containing 5 sugar probes that are taken up in different parts of the gut. These sugars are later recovered in the urine at two different time points, reflecting gastroduodenal, small intestinal and colonic permeability.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent signed by study participant
  • Age ≥ 55 years
  • Mentally and physically fit to complete questionnaires during the study period

Exclusion criteria

  • 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.
  • Intake of medications know to change the inflammatory status (i.e proton pump inhibitors, antibiotic, anti-inflammatory medication (including NSAIDs)

Treatment and study plan

Naxus

Dietary Supplement

Non-digestible polysaccharides arabinoxylan (Naxus)

Other names: Placebo

Oatwell

Dietary Supplement

Non-digestible polysaccharides oat beta-glucan (Oatwell)

Placebo

Dietary Supplement

Maltodextrin as placebo

Primary outcomes

  1. Changes in delta indomethacin challenged permeability at end of intervention period

    Time frame: 6 weeks

    In vivo multi-sugar permeability test

Secondary outcomes

  1. Changes in faecal microbiota composition at end of intervention period

    Time frame: 6 weeks

    16S rRNA-based sequencing

  2. Changes in cytokine levels at end of intervention period

    Time frame: 6 weeks

    Multiplex assay for IL-1β, IL-6, IL-8, IL-10, IL-2, IL-12p70, IFN-γ and TNF-α

  3. Changes in reactive oxygen species levels at end of intervention period

    Time frame: 6 weeks

    FORT test for hydrogen peroxide

  4. Changes in gastrointestinal symptom questionnaire scores at end of intervention period

    Time frame: 6 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.

  5. Changes in hospital and anxiety depression scores at end of intervention period

    Time frame: 6 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.

  6. Changes in perceived stress scale scores at end of intervention period

    Time frame: 6 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.

  7. Changes in quality of life questionnaire scores at end of intervention period

    Time frame: 6 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

  • Fibebiotics consortium (EU)

Registry information

Official study title

The Influence of Prebiotic Supplementation on Intestinal Barrier Function in Elderly: A Randomized Placebo Controlled Clinical Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 8, 2017
Registry last updated
Aug 23, 2018

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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