Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05348694
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2022-04-18
Brief Title:
OsteoPreP Food Supplements for Postmenopausal Bone Health
Sponsor:
Australian Catholic University
Organization:
Australian Catholic University
Study Overview
Official Title:
OsteoPreP The Effect of Probiotic Supplementation on Bone Muscle and Glucose Metabolism in Postmenopausal Women A Randomised Placebo-controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
OsteoPreP
Brief Summary:
To evaluate the effect of 12 months of supplementation with a probiotic probiotic plus prebiotic 2 capsules per day on relative change in total volumetric bone density measured using high resolution peripheral quantitative computed tomography HR-pQCT of the distal tibia
Detailed Description:
It is well established that bone loss occurs throughout life after the attainment of peak bone mass which is usually reached by the end of the second decade of life During the first 5-8 years following menopause women experience an accelerated bone loss which is then followed by a slower phase of decline in bone mineral density BMD As over 40 of all women in Australia will suffer an osteoporotic fragility fracture in their lifetime investigating interventions that can prevent bone loss in postmenopausal women is a critical focus The menopausal transition is also associated with an increased risk of cardiovascular disease diabetes and cognitive decline These conditions and their treatments can also affect bone health
Previous research has indicated a potential link between the gut microbiome and bone health Animal studies indicate that interventions affecting the gut microbiome may be successful in reducing bone loss but human data is limited Moreover there is an emerging body of evidence linking the gut microbiome to cognitive muscle and cardiometabolic function Such studies indicate that probiotics healthy gut bacteria or prebiotics food for healthy bacteria eg fibre can increase the amount of short chain fatty acids - such as butyrate -produced by the bacteria in the gut which may mediate the beneficial effects of improving gut health
The proposed study is a double-blind placebo-controlled randomised trial which will investigate whether consuming a probiotic supplement containing inulin a prebiotic soluble fibre twice daily for 12 months will improve bone health in postmenopausal women In addition secondary outcomes will measure the effect of the intervention on immune system modulation and cognition as well as musculoskeletal and metabolic function as potential mediators
One hundred and sixty postmenopausal women residing in Melbourne Victoria Australia who are at least one year from their final menses will be recruited from the community via a mail out advertisements in newspapers social media flyers as well as a landing page on an ACU managed website The investigators have also applied for assisted mail outs through Services Australia for recruitment purposes Services Australia is able to extract names and addresses of some target study demographics females living in Melbourne aged between 40 and 65 from the Medicare database and mail them the study details on our behalf Those wishing to participate will undergo a series of baseline assessments inclusive of bone mineral density scans blood and stool sampling and physical activity and lifestyle questionnaires They will then be randomised in a blinded fashion to consume one of the following two supplements
Placebo control group n 80 Placebo capsule - 2 capsules per day
Probiotics group n80 Probiotic capsule - 2 capsules per day
Study outcomes will be measured at baseline 6 months and 12 months In addition participants will be contacted via the telephone and email at three-month and nine-month timepoints to report any adverse responses to the supplementation At the 12-month time point participants will cease supplementation and immediately within 24 hours attend a post intervention assessment and will complete identical assessment measures to those they did at baseline Finally at 2 weeks post supplementation cessation participants will be asked to attend an appointment to provide a final stool sample
If it can be confirmed that long term consumption of a probiotic supplement can have beneficial effects on bone health muscle health and metabolic health in postmenopausal women this intervention could be recommended in the prevention of osteoporosis and associated musculoskeletal and metabolic conditions
Previous research has indicated a potential link between the gut microbiome and bone health Animal studies indicate that interventions affecting the gut microbiome may be successful in reducing bone loss but human data is limited Moreover there is an emerging body of evidence linking the gut microbiome to cognitive muscle and cardiometabolic function Such studies indicate that probiotics healthy gut bacteria or prebiotics food for healthy bacteria eg fibre can increase the amount of short chain fatty acids - such as butyrate -produced by the bacteria in the gut which may mediate the beneficial effects of improving gut health
The proposed study is a double-blind placebo-controlled randomised trial which will investigate whether consuming a probiotic supplement containing inulin a prebiotic soluble fibre twice daily for 12 months will improve bone health in postmenopausal women In addition secondary outcomes will measure the effect of the intervention on immune system modulation and cognition as well as musculoskeletal and metabolic function as potential mediators
One hundred and sixty postmenopausal women residing in Melbourne Victoria Australia who are at least one year from their final menses will be recruited from the community via a mail out advertisements in newspapers social media flyers as well as a landing page on an ACU managed website The investigators have also applied for assisted mail outs through Services Australia for recruitment purposes Services Australia is able to extract names and addresses of some target study demographics females living in Melbourne aged between 40 and 65 from the Medicare database and mail them the study details on our behalf Those wishing to participate will undergo a series of baseline assessments inclusive of bone mineral density scans blood and stool sampling and physical activity and lifestyle questionnaires They will then be randomised in a blinded fashion to consume one of the following two supplements
Placebo control group n 80 Placebo capsule - 2 capsules per day
Probiotics group n80 Probiotic capsule - 2 capsules per day
Study outcomes will be measured at baseline 6 months and 12 months In addition participants will be contacted via the telephone and email at three-month and nine-month timepoints to report any adverse responses to the supplementation At the 12-month time point participants will cease supplementation and immediately within 24 hours attend a post intervention assessment and will complete identical assessment measures to those they did at baseline Finally at 2 weeks post supplementation cessation participants will be asked to attend an appointment to provide a final stool sample
If it can be confirmed that long term consumption of a probiotic supplement can have beneficial effects on bone health muscle health and metabolic health in postmenopausal women this intervention could be recommended in the prevention of osteoporosis and associated musculoskeletal and metabolic conditions
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