Prebiotic Supplementation and Intestinal Barrier Function in Elderly: a RCT

Örebro University, Sweden

Status: Completed

Conditions: Prebiotics; Aged

Treatments: Dietary Supplement: Oatwell; Dietary Supplement: Placebo; Dietary Supplement: Naxus

Study type: Interventional

Funder types: Other

Identifiers

NCT03336385

FIT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Maltodextrin 12 gram used as placebo

Treatment:

Dietary Supplement: Placebo

Naxus

Active Comparator group

Description:

Naxus contains the wheat-derived prebiotic fibre Arabinoxylan

Treatment:

Dietary Supplement: Naxus

Oatwell

Active Comparator group

Description:

Oatwell contains an oat-derived prebiotic beta-glucan fibre

Treatment:

Dietary Supplement: Oatwell