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

Örebro University, Sweden

Status

Completed

Conditions

Prebiotics

Elderly

Bowel Symptoms

Treatments

Dietary Supplement: yeast-beta glucan

Study type

Interventional

Funder types

Other

Identifiers

NCT05584254

FODI

Details and patient eligibility

About

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.

Full description

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.

Enrollment

43 patients

Sex

All

Ages

55 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

43 participants in 3 patient groups

Elderly with gastrointestinal symptoms

Experimental group

Description:

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.

Treatment:

Dietary Supplement: yeast-beta glucan

Senior orienteers

No Intervention group

Description:

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

Young healthy adults

No Intervention group

Description:

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