Galactooligosaccharide and Aging

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

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.

Study Overview

• Status: Recruiting
• Conditions: Muscle Loss
• Intervention / Treatment: Dietary supplement: Prebiotic; Dietary supplement: Placebo control

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam J Collins; Phone Number: 07710611694; Email: ac3413@bath.ac.uk
• Study Contact Backup: Name: Javier T Gonzalez; Phone Number: 01225385518; Email: jg833@bath.ac.uk

Study Locations

• United Kingdom
  • Bath And NE Somerset
    • Bath, Bath And NE Somerset, United Kingdom, BA2 7AY
      • Recruiting
      • University of Bath
      • Contact: Adam Collins; Phone Number: 07710611694; Email: ac3413@bath.ac.uk
      • Principal Investigator: Adam Collins Collins, MSc
      • Principal Investigator: Javier Gonzalez, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged 65-85 years
• Able to rise from a chair without using arms

Exclusion Criteria:

• Use of products marketed as prebiotics, probiotics or synbiotics within 4 weeks prior to study entry (e.g., Yakult, Actimel, Activia, VSL#3, Kefir). Regular cheese or yogurt containing lactic acid bacteria are not an exclusion criterion

  • Systemic antibiotic or antimycotic treatment 6 weeks prior to study entry.
  • Following diets likely to affect study outcomes: e.g., low FODMAP, KETO/high-fat, gluten free/coeliac, paleo, weight loss, caloric restriction, low-carb, 5:2/whole day energy restriction, Atkins/high-protein, sugar-free, single-food, juicing/any day of juicing, any other restriction diet (e.g. very low calorie), or vegan diets (GOS is derived from cow's milk)
  • Meeting physical activity guidelines for older adults:
• Activities that improve strength, flexibility and balance at least two days per week

• At least 150 minutes of moderate-intensity activity, or 75 minutes of vigorous activity

  • Body mass loss of ≥ 5% in preceding 6 months
  • History of injury or surgery that would affect physical ability to undertake physical tests
  • History of gastrointestinal disease (e.g., inflammatory bowel disease, irritable bowel syndrome)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GOS; Galactooligosaccharide (GOS) is a prebiotic supplement. Taken once daily for the duration for the intervention	Dietary supplement: Prebiotic; Commercially available supplement (Bimuno)
Placebo Comparator: Placebo; Maltodextrin placebo taken once daily for the duration of the intervention	Dietary supplement: Placebo control; maltodextrin control supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mid-thigh muscle cross sectional area	pQCT assessment of mid-thigh cross sectional area	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short performance physical battery	composite test of balance, gait speed and chair stand tests where performance on each three tests scores of maximum of 4 points, combined to score a maximum of 12 points	16 weeks
Handgrip strength	dominant and non-dominant hand scores	16 weeks
appendicular lean mass/height^2 (kilograms/metres^2)	assessed via DEXA scan	16 weeks
gait speed	4m gait speed at usual walking pace (metres/second)	16 weeks
chair stand	5 time chair stand (seconds)	16 weeks

Collaborators and Investigators

• Sponsor: University of Bath

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): October 6, 2025
• Study Completion (Estimated): October 6, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: prebiotic; aging; gut microbiome; sarcopenia; physical function
• Other Study ID Numbers: 239308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No