Galactooligosaccharide and Aging

NCT06411964 | Recruiting

• 1 other identifier: 239308
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

sarcopenia; physical function; aging; gut microbiome; prebiotic

Outcome Measures

Primary Outcomes (1)

• Mid-thigh muscle cross sectional area

  pQCT assessment of mid-thigh cross sectional area

  16 weeks

Secondary Outcomes (5)

• Short performance physical battery

  16 weeks

• Handgrip strength

  16 weeks

• appendicular lean mass/height^2 (kilograms/metres^2)

  16 weeks

• gait speed

  16 weeks

• chair stand

  16 weeks

Study Arms (2)

GOS

EXPERIMENTAL

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

Dietary Supplement: Prebiotic

Placebo

PLACEBO COMPARATOR

Maltodextrin placebo taken once daily for the duration of the intervention

Dietary Supplement: Placebo control

Interventions

Prebiotic DIETARY_SUPPLEMENT

Commercially available supplement (Bimuno)

GOS

Placebo control DIETARY_SUPPLEMENT

maltodextrin control supplement

Placebo

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Bath: lead

Study Sites (1)

University of Bath

Bath, Bath and NE Somerset, BA2 7AY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy; Sarcopenia

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Central Study Contacts

Adam J Collins

CONTACT

07710611694; ac3413@bath.ac.uk

Javier T Gonzalez

CONTACT

01225385518; jg833@bath.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 14, 2024
• Study Start: May 2, 2024
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)