Prebiotic Supplementation and Intestinal Barrier Function in Elderly: a RCT

NCT03336385 | Completed

• 1 other identifier: FIT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prebiotics; Aged

Keywords

Older adults; Prebiotics; Intestinal permeability; NSAIDS

Outcome Measures

Primary Outcomes (1)

• Changes in delta indomethacin challenged permeability at end of intervention period

  In vivo multi-sugar permeability test

  6 weeks

Secondary Outcomes (7)

• Changes in faecal microbiota composition at end of intervention period

  6 weeks

• Changes in cytokine levels at end of intervention period

  6 weeks

• Changes in reactive oxygen species levels at end of intervention period

  6 weeks

• Changes in gastrointestinal symptom questionnaire scores at end of intervention period

  6 weeks

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

  6 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Maltodextrin 12 gram used as placebo

Dietary Supplement: Placebo

Naxus

ACTIVE COMPARATOR

Naxus contains the wheat-derived prebiotic fibre Arabinoxylan

Dietary Supplement: Naxus

Oatwell

ACTIVE COMPARATOR

Oatwell contains an oat-derived prebiotic beta-glucan fibre

Dietary Supplement: Oatwell

Interventions

Naxus DIETARY_SUPPLEMENT

Non-digestible polysaccharides arabinoxylan (Naxus)

Also known as: Placebo

Naxus

Oatwell DIETARY_SUPPLEMENT

Non-digestible polysaccharides oat beta-glucan (Oatwell)

Oatwell

Placebo DIETARY_SUPPLEMENT

Maltodextrin as placebo

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Fibebiotics consortium (EU): collaborator

Study Sites (1)

Örebro University

Örebro, 701 82, Sweden

Location

Study Officials

• Robert J Brummer, MD, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: The study participants were allocated through block randomization into three different intervention arms that ran in parallell throughout the study

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: November 8, 2017
• Study Start: October 12, 2015
• Primary Completion: December 18, 2015
• Study Completion: December 18, 2015
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

SE (1)