Aged, Prebiotics
Conditions
Keywords
Older adults, Prebiotics, Intestinal permeability, NSAIDS
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTNaxus
Non-digestible polysaccharides arabinoxylan (Naxus)
DIETARY_SUPPLEMENTOatwell
Non-digestible polysaccharides oat beta-glucan (Oatwell)
DIETARY_SUPPLEMENTPlacebo
Maltodextrin as placebo
Sponsors
Fibebiotics consortium (EU)
Örebro University, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The randomization list was generated and provided by the Fibebiotics consortium (part of the EU framework 7 program) using unique study codes for participants. All study product labels were coded by a third-party. All investigators and study participants remained blinded until final analysis
Intervention model description
The study participants were allocated through block randomization into three different intervention arms that ran in parallell throughout the study
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in delta indomethacin challenged permeability at end of intervention period | 6 weeks | In vivo multi-sugar permeability test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in cytokine levels at end of intervention period | 6 weeks | Multiplex assay for IL-1β, IL-6, IL-8, IL-10, IL-2, IL-12p70, IFN-γ and TNF-α |
| Changes in reactive oxygen species levels at end of intervention period | 6 weeks | FORT test for hydrogen peroxide |
| Changes in gastrointestinal symptom questionnaire scores at end of intervention period | 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. |
| Changes in faecal microbiota composition at end of intervention period | 6 weeks | 16S rRNA-based sequencing |
| Changes in perceived stress scale scores at end of intervention period | 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. |
| Changes in quality of life questionnaire scores at end of intervention period | 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. |
| Changes in hospital and anxiety depression scores at end of intervention period | 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. |
Countries
Sweden
Outcome results
None listed