Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411964
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-07
Brief Title:
Galactooligosaccharide and Aging
Sponsor:
University of Bath
Organization:
University of Bath
Study Overview
Official Title:
Does Galactooligosaccharide Supplementation Improve Markers of Skeletal Muscle Health in Elderly Individuals
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 29 g galactooligosaccharide per day for 16 weeks in the form of one sachet 365 g of Bimuno Daily
The PLACEBO group will supplement with 365 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
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 29 g galactooligosaccharide per day for 16 weeks in the form of one sachet 365 g of Bimuno Daily
The PLACEBO group will supplement with 365 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None