Does Galactooligosaccharide Supplementation Improve Markers of Skeletal Muscle Health in Elderly Individuals?

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Sarcopenia is a progressive muscle disease, most commonly affecting older individuals, that is categorised by 1) low muscle strength, 2) low muscle quantity or quality, and 3) low physical performance. This disease has several negative implications for human health, including an increased risk of falls, fractures, mobility limitations, and mortality. Sarcopenia also imposes significant burden on healthcare systems. For example, it was estimated that a 10% reduction in the prevalence of sarcopenia would save the US healthcare system $1.1 billion per year. Strategies to reduce the incidence and severity of sarcopenia are therefore of great interest. One potential cause for sarcopenia is long-term, low-level inflammation, which can occur for a number of reasons. One cause may relate to the intestinal wall becoming more susceptible to leaking of toxic particles. Evidence suggests that prebiotic supplementation can reduce this 'leakage'. Galactooligosaccharide (a prebiotic) has previously been shown to reduce inflammation in elderly individuals. The investigators hypothesise that galactooligosaccharide will improve physical function in the elderly indirectly via a reduction in inflammation. This will be a randomised, placebo-controlled, double-blind, parallel study. 32 elderly individuals (65-85 years; mix of males and females) will be randomised to one of two groups, GOS or PLACEBO. The GOS group will supplement their diet with 2.9 g galactooligosaccharide per day for 16 weeks in the form of one sachet (3.65 g) of Bimuno® Daily. The PLACEBO group will supplement with 3.65 g maltodextrin per day for 16 weeks. The study will involve one screening visit and two main trials (baseline and 16 weeks). For the main trials, participants will complete the short physical performance battery (SPPB) and handgrip strength test. In addition, participants will provide blood, urine and faecal samples, as well as a dual-energy x-ray absorptiometry (DEXA), and a peripheral quantitative computed tomography (pQCT) scan.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 85
Healthy Volunteers: t
View:

• Aged 65-85 years

• Able to rise from a chair without using arms

Locations
Other Locations
United Kingdom
University of Bath
RECRUITING
Bath
Contact Information
Primary
Adam J Collins
ac3413@bath.ac.uk
07710611694
Backup
Javier T Gonzalez
jg833@bath.ac.uk
01225385518
Time Frame
Start Date: 2024-05-02
Estimated Completion Date: 2025-10-06
Participants
Target number of participants: 30
Treatments
Experimental: GOS
Galactooligosaccharide (GOS) is a prebiotic supplement. Taken once daily for the duration for the intervention
Placebo_comparator: Placebo
Maltodextrin placebo taken once daily for the duration of the intervention
Related Therapeutic Areas
Sponsors
Leads: University of Bath

This content was sourced from clinicaltrials.gov