Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389539
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-24
Brief Title:
Synbiotic to Attenuate Resorption of the Skeleton
Sponsor:
Hebrew SeniorLife
Organization:
Hebrew SeniorLife
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Clinical Food Trial of ProbioticPrebiotic Medical Food for the Dietary Management of Age Related Bone Loss
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
STARS
Brief Summary:
This randomized double blind placebo controlled clinical trial will test the efficacy of a probioticprebiotic combination synbiotic on the skeleton in older women
Detailed Description:
There are currently no consistent guidelines on how middle aged and older adults can maintain healthy bone mass as they age Hence there is an unmet need for safe and effective dietary interventions for the metabolic processes underlying bone loss The objective of this project is to test the efficacy of a probioticprebiotic combination or synbiotic ie Solarea Bio defined microbial assemblage 111 SBD111 medical food on the skeleton of older women
Aim 1 To determine the effect of 18 months of daily intake of SBD111 medical food on the primary outcome of lumbar spine dual energy x-ray absorptiometry DXA bone mineral density BMD and secondary outcomes Biomechanical Computed Tomography analysis BCT-derived vertebral compressive strength volumetric BMD vBMD and markers of bone turnover in women
Hypothesis 1a BMD vertebral compressive strength and vBMD will be greater in women randomized to SBD111 medical food compared to placebo
Hypothesis 1b Biochemical markers of bone turnover will decrease with SBD111 medical food use compared to placebo
Aim 2 To determine the effect of 18 months of daily intake of SBD111 medical food on markers of inflammation and gut microbiome function secondary outcomes in women
Hypothesis 2a Markers of inflammation interleukin 17A IL17A and tumor necrosis factor alpha TNF-α will be reduced with SBD111 medical food use compared to placebo
Hypothesis 2b Functional genes and pathways related to fiber breakdown glycosyl hydrolases menaquinone 7 production and short chain fatty acid SCFA production will be enriched in stool metagenomes and upregulated in stool metatranscriptomes from those receiving SBD111 medical food compared to placebo
Eligible women will be randomized to SBD111 medical food versus placebo capsules for 18 months Assessments will be made at the in-person baseline visit 9-month and 18-month follow-up visits as well as monthly telephone calls
The primary outcome is lumbar spine BMD gcm2 and secondary outcomes include vertebral compressive strength N vBMD gcm3 and bone biomarkers
Intent-to-treat analysis will be conducted for all endpoints
Aim 1 To determine the effect of 18 months of daily intake of SBD111 medical food on the primary outcome of lumbar spine dual energy x-ray absorptiometry DXA bone mineral density BMD and secondary outcomes Biomechanical Computed Tomography analysis BCT-derived vertebral compressive strength volumetric BMD vBMD and markers of bone turnover in women
Hypothesis 1a BMD vertebral compressive strength and vBMD will be greater in women randomized to SBD111 medical food compared to placebo
Hypothesis 1b Biochemical markers of bone turnover will decrease with SBD111 medical food use compared to placebo
Aim 2 To determine the effect of 18 months of daily intake of SBD111 medical food on markers of inflammation and gut microbiome function secondary outcomes in women
Hypothesis 2a Markers of inflammation interleukin 17A IL17A and tumor necrosis factor alpha TNF-α will be reduced with SBD111 medical food use compared to placebo
Hypothesis 2b Functional genes and pathways related to fiber breakdown glycosyl hydrolases menaquinone 7 production and short chain fatty acid SCFA production will be enriched in stool metagenomes and upregulated in stool metatranscriptomes from those receiving SBD111 medical food compared to placebo
Eligible women will be randomized to SBD111 medical food versus placebo capsules for 18 months Assessments will be made at the in-person baseline visit 9-month and 18-month follow-up visits as well as monthly telephone calls
The primary outcome is lumbar spine BMD gcm2 and secondary outcomes include vertebral compressive strength N vBMD gcm3 and bone biomarkers
Intent-to-treat analysis will be conducted for all endpoints
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