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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GOS | Experimental | Galactooligosaccharide (GOS) is a prebiotic supplement. Taken once daily for the duration for the intervention |
|
| Placebo | Placebo Comparator | Maltodextrin placebo taken once daily for the duration of the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic | Dietary Supplement | Commercially available supplement (Bimuno) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mid-thigh muscle cross sectional area | pQCT assessment of mid-thigh cross sectional area | 16 weeks |
| 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 |
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Inclusion Criteria:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam J Collins | Contact | 07710611694 | ac3413@bath.ac.uk | |
| Javier T Gonzalez | Contact | 01225385518 | jg833@bath.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bath | Recruiting | Bath | Bath and NE Somerset | BA2 7AY | United Kingdom |
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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double blind
| Placebo control |
| Dietary Supplement |
maltodextrin control supplement |
|
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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |