None listed
Conditions
Brief summary
Osteoporosis is a disease characterized by bone fragility resulting in bone fractures, which leads to increased morbidity and mortality. Following menopause, bone resorption exceeds bone formation, leading to net bone loss and bone fragility. There is an emerging body of evidence linking the gut microbiome and probiotic ingestion to skeletal, muscle, cognitive, and cardiometabolic function. The aim of this study is to investigate whether a taking a probiotic supplement .twice daily for 12 months positively impacts the rate of bone loss in recently psotmenopausal women 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 early postmenopausal women, aged 40-65 years. 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. It is hypothesised that the probiotic supplementation will improve markers of bone health, muscle health, and metabolic health in postmenopausal women.
Interventions
Participants will be randomized to one of the below arms and asked to consume the assigned supplement daily for a period of 12 months.
The active arm (probiotic capsule with prebiotic components [inulin]) and placebo control (magnesium stearate) will be taken twice daily.
• Probiotic treatment group (n = 80):
WBF-038; a proprietary formulation of the following strains: Akkermansia muciniphila, Clostridium butyricum, Clostridium beijerinckii, Anaerobutyricum hallii, Bifidobacterium infantis, plu
Participants will be randomized to one of the below arms and asked to consume the assigned supplement daily for a period of 12 months. The active arm (probiotic capsule with prebiotic components [inulin]) and placebo control (magnesium stearate) will be taken twice daily. • Probiotic treatment group (n = 80): WBF-038; a proprietary formulation of the following strains: Akkermansia muciniphila, Clostridium butyricum, Clostridium beijerinckii, Anaerobutyricum hallii, Bifidobacterium infantis, plus chicory inulin and magnesium stearate. Exact doses will be disclosed after IP restrictions are met. Adherence to the study supplementation will be recorded by participants checking a daily log/calendar for complete, partial and zero intake days.
Sponsors
Australian Catholic University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
• Postmenopausal women • Caucasian (due to significant differences in BMD and bone remodeling between ethnicities) • Between 1 and 4 years since final menses • Signed informed consent • Stated availability throughout the entire study period • Mental ability to understand and willingness to fulfill all the details of the protocol • 'Up to date' vaccination status • Able to walk without the use of an aid
Exclusion criteria
• Diagnosis of osteoporosis • Low trauma fracture after 50 years of age • T-score of -2.5 or less at the femoral neck or lumbar spine (L1-L4) on the DXA scan at screening visit • HbA1c equal to or greater than 6.5% at screening visit • Blood pressure at screening visit of systolic >180 mmHg and/or diastolic >120 mmHg • Untreated hyperthyroidism • Rheumatoid arthritis • Diagnosed with a disease causing secondary osteoporosis or malabsorption: chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, type 1/type 2 diabetes, or chronic liver disease • Bariatric surgery • Recently diagnosed malignancy (within the last 5 years) • Current or recent oral corticosteroid use (any dose within the last 3 months, or 5mg of Prednisolone (or equivalent) or a higher daily dose for 14 days or more 3-12 months prior to screening) • Use of antiresorptive therapy, including systemic hormone replacement therapy, bisphosphonates, strontium ranelate (current or during the last 3 years) • Use of teriparatide (current or during the last 3 years) • Participation in other clinical intervention trials • Antibiotics treatment 2 months prior to inclusion • Unwilling to cease taking other probiotic or prebiotic supplements (current use)
Outcome results
None listed