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

NCT05584254 | Completed

• 1 other identifier: FODI
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Elderly; Bowel Symptoms; Prebiotics

Keywords

elderly; prebiotics; permeability; clinical trial; Microbiota; Health

Outcome Measures

Primary Outcomes (8)

• Intestinal permeability at baseline (before indomethacin)

  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.

  Day 1

• Intestinal permeability at baseline (after indomethacin)

  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.

  Day 1

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

  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.

  3 weeks

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

  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.

  3 weeks

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

  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.

  3 weeks

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

  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.

  3 weeks

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

  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.

  3 weeks

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

  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.

  3 weeks

Secondary Outcomes (18)

• Microbiota diversity - at baseline

  Day 1

• Bacterial species - at baseline

  Day 1

• Changes in microbiota diversity 3 weeks after study supplementation 1

  3 weeks

• Changes in bacterial species 3 weeks after study supplementation 1

  3 weeks

• Changes in microbiota diversity 3 weeks after study supplementation 2

  3 weeks

Study Arms (3)

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.

Dietary Supplement: yeast-beta glucan

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.

Interventions

yeast-beta glucan DIETARY_SUPPLEMENT

Elderly with gastrointestinal symptoms

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Kerry Group: collaborator

Study Sites (1)

Campus USÖ, Örebro University

Örebro, 70362, Sweden

Location

Study Officials

• Robert J Brummer, PhD/MD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: 3 study products (2 different forms of yeast-beta glucan and a placebo) taken in a cross-over design.

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 18, 2022
• Study Start: April 1, 2015
• Primary Completion: August 14, 2017
• Study Completion: August 14, 2017
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)