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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05348694




Registration number
NCT05348694
Ethics application status
Date submitted
18/04/2022
Date registered
27/04/2022

Titles & IDs
Public title
OsteoPreP: Food Supplements for Postmenopausal Bone Health
Scientific title
OsteoPreP: The Effect of Probiotic Supplementation on Bone, Muscle, and Glucose Metabolism in Postmenopausal Women: A Randomised Placebo-controlled Trial
Secondary ID [1] 0 0
2021-122HC
Universal Trial Number (UTN)
Trial acronym
OsteoPreP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postmenopausal Osteopenia 0 0
Bone Loss, Age Related 0 0
Age-Related Sarcopenia 0 0
Glucose Metabolism Disorders 0 0
Age-related Cognitive Decline 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pendulum WBF-038
Treatment: Other - Pendulum Placebo

Active comparator: Pendulum WBF-038 - Pendulum 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 - 1 capsule with the morning meal and 1 capsule with the evening meal for 12 months.

Placebo comparator: Pendulum Placebo - Pendulum Placebo containing Magnesium stearate - 1 capsule with the morning meal and 1 capsule with the evening meal for 12 months.


Treatment: Other: Pendulum WBF-038
All bacteria contained in Pendulum WBF-038 are commensal organisms that have been repeatedly documented to inhabit the human gastrointestinal tract under normal circumstances. Pendulum's WBF-038 is a proprietary formulation of the following strains: Akkermansia muciniphila, Clostridium butyricum, Clostridium beijerinckii, Anaerobutyricum hallii, Bifidobacterium infantis, plus chicory inulin and magnesium stearate. The organisms were grown under controlled conditions consistent with Good Manufacturing Practices (GMP) and employ no animal-derived products. All ingredients utilized during manufacturing were food grade and qualified as generally recognized as safe (GRAS).

The product is provided as acid-resistant capsules in bottles that are to be stored refrigerated at 4?.

Treatment: Other: Pendulum Placebo
Pendulum placebo capsules containing magnesium stearate
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total volumetric bone mineral density of the distal tibia
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Bone mineral density of the lumbar spine
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Bone mineral density of the hip
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Tibia and radius trabecular bone volume
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Tibia and radius cortical area
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Tibia and radius cortical volumetric bone mineral density
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Total volumetric bone mineral density of the distal radius
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Serum C-terminal cross-linking telopeptide of type I collagen (ßCTX-I) - bone turnover marker
Timepoint [7] 0 0
6 months and 12 months
Secondary outcome [8] 0 0
Serum procollagen type 1 N-terminal propeptide (P1NP) - bone turnover marker
Timepoint [8] 0 0
6 months and 12 months
Secondary outcome [9] 0 0
Serum osteocalcin (OC) - bone turnover marker
Timepoint [9] 0 0
6 months and 12 months
Secondary outcome [10] 0 0
Short-chain fatty acids (SCFAs)
Timepoint [10] 0 0
6 months, 12 months, and 2 weeks post intervention
Secondary outcome [11] 0 0
16s rRNA genetic sequencing of the gut microbiota
Timepoint [11] 0 0
6 months, 12 months, and 2 weeks post intervention
Secondary outcome [12] 0 0
Fasting blood glucose
Timepoint [12] 0 0
6 months and 12 months
Secondary outcome [13] 0 0
Glycated haemoglobin (HbA1c)
Timepoint [13] 0 0
6 months and 12 months
Secondary outcome [14] 0 0
Lower leg muscle area
Timepoint [14] 0 0
12 months
Secondary outcome [15] 0 0
Lean body mass
Timepoint [15] 0 0
12 months
Secondary outcome [16] 0 0
Grip strength
Timepoint [16] 0 0
6 months and 12 months
Secondary outcome [17] 0 0
High-sensitivity C-reactive protein (hs-CRP)
Timepoint [17] 0 0
6 months and 12 months
Secondary outcome [18] 0 0
Regulatory T lymphocytes (Tregs)
Timepoint [18] 0 0
12 months
Secondary outcome [19] 0 0
Oral glucose tolerance test (OGTT)
Timepoint [19] 0 0
6 months and 12 months
Secondary outcome [20] 0 0
Muscle tissue glycogen content
Timepoint [20] 0 0
6 months and 12 months
Secondary outcome [21] 0 0
Muscle tissue triglyceride content
Timepoint [21] 0 0
6 months and 12 months
Secondary outcome [22] 0 0
Muscle tissue type 1 fibre composition
Timepoint [22] 0 0
6 months and 12 months
Secondary outcome [23] 0 0
Lipocalin2
Timepoint [23] 0 0
6 months, 12 months, and 2 weeks post intervention
Secondary outcome [24] 0 0
Cogstate One back Test Cognitive performance test
Timepoint [24] 0 0
6 months and 12 months
Secondary outcome [25] 0 0
Cogstate Groton Maze Learning Test Cognitive performance test
Timepoint [25] 0 0
6 months and 12 months
Secondary outcome [26] 0 0
Cogstate Continuous Paired Associate Learning Test Cognitive performance test
Timepoint [26] 0 0
6 months and 12 months
Secondary outcome [27] 0 0
Cogstate Social Emotional Cognition Test Cognitive performance test
Timepoint [27] 0 0
6 months and 12 months
Secondary outcome [28] 0 0
Depression, Anxiety and Stress Scale 21
Timepoint [28] 0 0
6 months and 12 months
Secondary outcome [29] 0 0
Gastrointestinal Symptom Rating Scale
Timepoint [29] 0 0
6 months and 12 months
Secondary outcome [30] 0 0
Plasma glucagon-like peptide 1
Timepoint [30] 0 0
6 months and 12 months
Secondary outcome [31] 0 0
Plasma peptide tyrosine-tyrosine
Timepoint [31] 0 0
6 months and 12 months
Secondary outcome [32] 0 0
Plasma adiponectin
Timepoint [32] 0 0
6 months and 12 months
Secondary outcome [33] 0 0
EuroQol Five Dimensions Quality of life Medical Outcome Survey
Timepoint [33] 0 0
6 months and 12 months
Secondary outcome [34] 0 0
Social Interaction Anxiety Scale
Timepoint [34] 0 0
6 months and 12 months
Secondary outcome [35] 0 0
The Warwick-Edinburgh Mental Wellbeing Scale
Timepoint [35] 0 0
6 months and 12 months
Secondary outcome [36] 0 0
Continuous blood glucose level monitoring for 10 days
Timepoint [36] 0 0
6 months and 12 months
Secondary outcome [37] 0 0
Fasting blood insulin
Timepoint [37] 0 0
6 months and 12 months
Secondary outcome [38] 0 0
Fat mass
Timepoint [38] 0 0
12 months
Secondary outcome [39] 0 0
Blood metabolomics
Timepoint [39] 0 0
12 months
Secondary outcome [40] 0 0
Office blood pressure
Timepoint [40] 0 0
6 months and 12 months
Secondary outcome [41] 0 0
The Visual Analogue Scale Pain Intensity
Timepoint [41] 0 0
6 months and 12 months
Secondary outcome [42] 0 0
Calprotectin
Timepoint [42] 0 0
6 months, 12 months, and 2 weeks post intervention
Secondary outcome [43] 0 0
Muscle mass
Timepoint [43] 0 0
12 months

Eligibility
Key inclusion criteria
* Postmenopausal women, 40-65 years old
* Caucasian (due to significant differences in BMD and bone remodelling between ethnicities)
* At least one year since final menses
* Signed informed consent
* Up to date Covid 19 vaccination status
* Able to walk without the use of an aid
* Stated availability throughout the entire study period
* Mental capacity to understand and willingness to fulfil all the details of the protocol
* Residing in Melbourne, Victoria, Australia
Minimum age
40 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Diagnosis of osteoporosis
* T-score of -2.5 or less at the femoral neck or lumbar spine (L1-L4) on the DXA scan at screening visit
* HbA1c =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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Australian Catholic University - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian Catholic University
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pendulum Therapeutics
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Curtin University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Hawley, PhD
Address 0 0
Australian Catholic University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05348694