Actively Recruiting

Phase Not Applicable
Age: 65Years - 85Years
All Genders
Healthy Volunteers
NCT06411964

Galactooligosaccharide and Aging

Led by University of Bath · Updated on 2024-05-16

30

Participants Needed

1

Research Sites

74 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Galactooligosaccharide and Aging

Who Can Participate

Age: 65Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 65-85 years
  • Able to rise from a chair without using arms
Not Eligible

You will not qualify if you...

  • Use of prebiotic, probiotic, or synbiotic products within 4 weeks prior to study entry (e.g., Yakult, Actimel, Activia, VSL#3, Kefir); regular cheese or yogurt with lactic acid bacteria allowed
  • Systemic antibiotic or antifungal treatment within 6 weeks prior to study entry
  • Following diets likely to affect study outcomes including low FODMAP, keto/high-fat, gluten free/coeliac, paleo, weight loss, caloric restriction, low-carb, 5:2 energy restriction, Atkins/high-protein, sugar-free, single-food, juicing, very low calorie, or vegan diets
  • Meeting physical activity guidelines for older adults: activities improving strength, flexibility, and balance at least twice weekly or at least 150 minutes moderate or 75 minutes vigorous activity per week
  • Body mass loss of 5% or more in the past 6 months
  • History of injury or surgery affecting ability to perform physical tests
  • History of gastrointestinal disease such as inflammatory bowel disease or irritable bowel syndrome

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Bath

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

Actively Recruiting

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Research Team

A

Adam J Collins

CONTACT

J

Javier T Gonzalez

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Galactooligosaccharide and Aging | DecenTrialz