Galactooligosaccharide and Aging

NCT ID: NCT06411964

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2025-10-06

Brief 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.

Conditions

Muscle Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

GOS

Galactooligosaccharide (GOS) is a prebiotic supplement. Taken once daily for the duration for the intervention

Group Type: EXPERIMENTAL

Prebiotic

Intervention Type: DIETARY_SUPPLEMENT

Commercially available supplement (Bimuno)

Placebo

Maltodextrin placebo taken once daily for the duration of the intervention

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: DIETARY_SUPPLEMENT

maltodextrin control supplement

Interventions

Prebiotic

Commercially available supplement (Bimuno)

Intervention Type: DIETARY_SUPPLEMENT

Placebo control

maltodextrin control supplement

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bath

OTHER

Sponsor Role: lead

Responsible Party

Adam Collins

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Bath

Bath, Bath and NE Somerset, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Adam J Collins

Role: CONTACT

ac3413@bath.ac.uk

07710611694

Javier T Gonzalez

Role: CONTACT

jg833@bath.ac.uk

01225385518

Facility Contacts

Adam Collins

Role: primary

ac3413@bath.ac.uk

07710611694

Other Identifiers

239308

Identifier Type: -

Identifier Source: org_study_id