Muscle LossNCT06411964
Galactooligosaccharide and Aging
A study testing Prebiotic in people with Muscle Loss, run by University of Bath at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Loss
- What is being tested?
- Prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 May 2024to 6 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65-85 years
- Able to rise from a chair without using arms
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Bath
Bath, Bath and NE Somerset, BA2 7AY
Adam Collins, 07710611694, ac3413@bath.ac.uk
Adam Collins Collins, MSc
About this study
Official title: 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.
Read more
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
- Being tested
- Prebiotic, Placebo control
- Keywords
- sarcopenia, physical function, aging, gut microbiome, prebiotic
- Medical subject headings
- Muscular Atrophy, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
Commercially available supplement (Bimuno)
Placebo controlDietary supplement
maltodextrin control supplement
| Study group | Role | What they receive |
|---|---|---|
| GOS | Experimental | Galactooligosaccharide (GOS) is a prebiotic supplement. Taken once daily for the duration for the intervention Receives: Dietary Supplement: Prebiotic |
| Placebo | Placebo comparator | Maltodextrin placebo taken once daily for the duration of the intervention Receives: Dietary Supplement: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid-thigh muscle cross sectional area
pQCT assessment of mid-thigh cross sectional area
Measured: 16 weeks
Secondary outcomes (5)
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
Measured: 16 weeks
Handgrip strength
dominant and non-dominant hand scores
Measured: 16 weeks
appendicular lean mass/height^2 (kilograms/metres^2)
assessed via DEXA scan
Measured: 16 weeks
gait speed
4m gait speed at usual walking pace (metres/second)
Measured: 16 weeks
chair stand
5 time chair stand (seconds)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start2 May 2024
- Primary completion6 Oct 2025 (estimated)
- Study completion6 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Collins, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411964
- Sponsor's protocol ID
- 239308
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Galactooligosaccharide Supplementation Improve Markers of Skeletal Muscle Health in Elderly Individuals?
- ClinicalTrials.gov ID
- NCT06411964
- Acronym / sponsor ID
- 239308
- Conditions
- Muscle Loss
- Keywords
- sarcopenia, physical function, aging, gut microbiome, prebiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 6 Oct 2025 (estimated)
- Study completion
- 6 Oct 2025 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GOS | Experimental | Dietary Supplement: PrebioticGalactooligosaccharide (GOS) is a prebiotic supplement. Taken once daily for the duration for the intervention |
| Placebo | Placebo comparator | Dietary Supplement: Placebo controlMaltodextrin placebo taken once daily for the duration of the intervention |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Aged 65-85 years
- Able to rise from a chair without using arms
Key exclusion criteria (9 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrebioticCommercially available supplement (Bimuno) | Dietary supplement | GOS |
| Placebo controlmaltodextrin control supplement | Dietary supplement | Placebo |
Primary outcome
Mid-thigh muscle cross sectional area
Time frame: 16 weeks
pQCT assessment of mid-thigh cross sectional area
5 secondary outcomes
Short performance physical battery
Time frame: 16 weeks
Handgrip strength
Time frame: 16 weeks
appendicular lean mass/height^2 (kilograms/metres^2)
Time frame: 16 weeks
gait speed
Time frame: 16 weeks
chair stand
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic in people with Muscle Loss, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam J Collins (07710611694, ac3413@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mid-thigh muscle cross sectional area (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.