Title

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

    N/A
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    43
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.
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.
Study Started
Apr 01
2015
Primary Completion
Aug 14
2017
Study Completion
Aug 14
2017
Last Update
Mar 23
2023

Dietary Supplement yeast-beta glucan

Elderly with gastrointestinal symptoms Experimental

The target group for the intervention and cohort of interest used for comparison of baseline characteristics between control groups. Went into a cross-over design with 2 yeast-derived beta-glucan supplements and a placebo.

Senior orienteers No Intervention

A model of healthy aged elderly used as a control group for the baseline characteristics.

Young healthy adults No Intervention

A cohort of young healthy adults used as a control group for the baseline characteristics.

Criteria

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.
No Results Posted