Postmenopausal OsteopeniaPhase 4OsteoPrePNCT05348694
OsteoPreP: Food Supplements for Postmenopausal Bone Health
A Phase 4 study testing Pendulum WBF-038 in people with Postmenopausal Osteopenia and Bone Loss, Age Related, run by Australian Catholic University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteopenia, Bone Loss, Age Related, Age-Related Sarcopenia
- What is being tested?
- Pendulum WBF-038
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteAustralia
- Study dates
- 1 May 2022to Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OsteoPreP: The Effect of Probiotic Supplementation on Bone, Muscle, and Glucose Metabolism in Postmenopausal Women: A Randomised Placebo-controlled Trial
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.
Read the 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, e.g. 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 (n=80): 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.
- Conditions
- Postmenopausal Osteopenia, Bone Loss, Age Related, Age-Related Sarcopenia, Glucose Metabolism Disorders, Age-related Cognitive Decline
- Being tested
- Pendulum WBF-038, Pendulum Placebo
- Keywords
- Postmenopausal bone loss, Probiotics, Volumetric bone mineral density, Short-chain fatty acids
- Medical subject headings
- Osteoporosis, Glucose Metabolism Disorders, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pendulum WBF-038Dietary supplement
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℃.
Pendulum PlaceboDietary supplement
Pendulum placebo capsules containing magnesium stearate
| Study group | Role | What they receive |
|---|---|---|
| Pendulum WBF-038 | Active comparator | 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. Receives: Dietary Supplement: Pendulum WBF-038 |
| Pendulum Placebo | Placebo comparator | Pendulum Placebo containing Magnesium stearate - 1 capsule with the morning meal and 1 capsule with the evening meal for 12 months. Receives: Dietary Supplement: Pendulum Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volumetric bone mineral density of the distal tibia
Percentage change in total volumetric bone density measured using high resolution peripheral quantitative computed tomography (HR-pQCT) of the distal tibia.
Measured: 12 months
Secondary outcomes (43)
Bone mineral density of the lumbar spine
Relative change in lumbar spine (L1-L4) bone mineral density (BMD) measured using dual energy X-ray absorptiometry (DXA)
Measured: 12 months
Bone mineral density of the hip
Relative change in total hip BMD measured using DXA
Measured: 12 months
Tibia and radius trabecular bone volume
Relative change in tibia and radius trabecular bone volume fraction measured using HR-pQCT
Measured: 12 months
Tibia and radius cortical area
Relative change in tibia and radius cortical area measured using HR-pQCT
Measured: 12 months
Tibia and radius cortical volumetric bone mineral density
Relative change in tibia and radius cortical volumetric BMD measured using HR-pQCT
Measured: 12 months
Total volumetric bone mineral density of the distal radius
Relative change in total volumetric BMD of the distal radius measured using HRpQCT
Measured: 12 months
Serum C-terminal cross-linking telopeptide of type I collagen (ßCTX-I) - bone turnover marker
Relative change in ßCTX-I in serum
Measured: 6 months and 12 months
Serum procollagen type 1 N-terminal propeptide (P1NP) - bone turnover marker
Relative change in P1NP levels in serum
Measured: 6 months and 12 months
Serum osteocalcin (OC) - bone turnover marker
Relative change in OC in serum
Measured: 6 months and 12 months
Short-chain fatty acids (SCFAs)
Relative change in SCFA levels (including butyrate) in stool
Measured: 6 months, 12 months, and 2 weeks post intervention
16s rRNA genetic sequencing of the gut microbiota
Relative change in species-level gut microbiota composition in stool using 16s rRNA sequencing
Measured: 6 months, 12 months, and 2 weeks post intervention
Fasting blood glucose
Relative change in fasted blood glucose levels in circulating blood
Measured: 6 months and 12 months
Glycated haemoglobin (HbA1c)
Relative change in HbA1c levels in circulating blood
Measured: 6 months and 12 months
Lower leg muscle area
Relative change in lower leg muscle area measured using HR-pQCT
Measured: 12 months
Lean body mass
Relative change in appendicular lean body mass measured using DXA
Measured: 12 months
Grip strength
Relative change in left and right hand grip strength measured using a hand dynamometer
Measured: 6 months and 12 months
High-sensitivity C-reactive protein (hs-CRP)
Relative change in hs-CRP levels in serum
Measured: 6 months and 12 months
Regulatory T lymphocytes (Tregs)
Relative change in circulating number of Tregs in blood
Measured: 12 months
Oral glucose tolerance test (OGTT)
Relative change in oral glucose tolerance in circulating blood
Measured: 6 months and 12 months
Muscle tissue glycogen content
Relative change in muscle tissue glycogen content obtained from a muscle biopsy
Measured: 6 months and 12 months
Muscle tissue triglyceride content
Relative change in muscle tissue triglyceride content obtained from a muscle biopsy
Measured: 6 months and 12 months
Muscle tissue type 1 fibre composition
Relative change in muscle tissue type 1 fibre proportion obtained from a muscle biopsy
Measured: 6 months and 12 months
Lipocalin2
Relative change in Lipocalin2 (intestinal inflammation) in stool
Measured: 6 months, 12 months, and 2 weeks post intervention
Cogstate One back Test Cognitive performance test
Relative change in speed of performance and number of errors in the One Back Test using the Cogstate cognitive assessment tool. Lower score = better performance
Measured: 6 months and 12 months
Cogstate Groton Maze Learning Test Cognitive performance test
Relative change in number of errors in the Groton Maze Learning Test using the Cogstate cognitive assessment tool. Lower score = better performance
Measured: 6 months and 12 months
Cogstate Continuous Paired Associate Learning Test Cognitive performance test
Relative change in accuracy of performance and number of errors in the Continuous Paired Associate Learning Test using the Cogstate cognitive assessment tool. Lower score = better performance
Measured: 6 months and 12 months
Cogstate Social Emotional Cognition Test Cognitive performance test
Relative change in accuracy of performance in the Social Emotional Cognition Test using the Cogstate cognitive assessment tool. Higher score = better performance
Measured: 6 months and 12 months
Depression, Anxiety and Stress Scale 21
Relative change in depression, anxiety and stress measured using the Depression Anxiety and Stress Scale 21 (DASS-21) questionnaire. The DASS-21 has a minimum score of 0 and a maximum score of 63 with higher scores indicating a worse outcome.
Measured: 6 months and 12 months
Gastrointestinal Symptom Rating Scale
Relative change in gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. The GSRS has a minimum score of 5 and a maximum score of 45 with higher scores indicating a worse outcome.
Measured: 6 months and 12 months
Plasma glucagon-like peptide 1
Relative change in gut hormone glucagon-like peptide 1 [GLP-1] in plasma
Measured: 6 months and 12 months
Plasma peptide tyrosine-tyrosine
Relative change in gut hormone peptide tyrosine-tyrosine [PYY] in plasma
Measured: 6 months and 12 months
Plasma adiponectin
Relative change adiponectin in plasma
Measured: 6 months and 12 months
EuroQol Five Dimensions Quality of life Medical Outcome Survey
Relative change in quality of life measured using the EuroQol Five Dimensions (EQ-5D) questionnaire. The EQ-5D has a minimum score of Level 1 and a maximum score of Level 5 with higher levels indicating a worse outcome
Measured: 6 months and 12 months
Social Interaction Anxiety Scale
Relative change in social anxiety measured using the Social Interaction Anxiety Scale (SIAS) questionnaire. The SIAS has a minimum score of 0 and a maximum score of 80 with higher scores indicating a worse outcome.
Measured: 6 months and 12 months
The Warwick-Edinburgh Mental Wellbeing Scale
Relative change in mental wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) questionnaire. The WEMWBS has a minimum score of 14 and a maximum score of 70 with higher scores indicating a better outcome.
Measured: 6 months and 12 months
Continuous blood glucose level monitoring for 10 days
Relative change in blood glucose (area under the curve) over 10 days measured using a continuous glucose monitoring device
Measured: 6 months and 12 months
Fasting blood insulin
Relative change in fasted blood insulin levels in circulating blood
Measured: 6 months and 12 months
Fat mass
Relative change in total body fat mass measured using DXA
Measured: 12 months
Blood metabolomics
Relative change in blood metabolites using liquid chromatography-mass spectrometry
Measured: 12 months
Office blood pressure
Relative change in Systolic and Diastolic blood pressure measured using a sphygmomanometer
Measured: 6 months and 12 months
The Visual Analogue Scale Pain Intensity
Relative change in current pain intensity measured using a visual analogue scale (VAS) pain intensity scale. The VAS has a minimum score of 0 and a maximum score of 10 with higher scores indicating a worse outcome.
Measured: 6 months and 12 months
Calprotectin
Relative change in calprotectin (intestinal inflammation) in stool
Measured: 6 months, 12 months, and 2 weeks post intervention
Muscle mass
Relative change in total body muscle mass measured using DXA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 May 2022
- Primary completion28 Mar 2024
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australian Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Pendulum Therapeutics, Curtin University
- Responsible party
- Sponsor
- Investigators
- John Hawley, PhD, Principal investigator, Australian Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348694
- Sponsor's protocol ID
- 2021-122HC
- Acronym
- OsteoPreP
- Status last verified
- Jan 2024
- First submitted
- 18 Apr 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turbic A, Vandenput L, Gandham A, Lorentzon M. Effects of Synbiotic Supplementation on Bone and Metabolic Health in Caucasian Postmenopausal Women: Rationale and Design of the OsteoPreP Trial. Nutrients. 2024 Dec 6;16(23):4219. doi: 10.3390/nu16234219.
PubMed 39683612
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OsteoPreP: The Effect of Probiotic Supplementation on Bone, Muscle, and Glucose Metabolism in Postmenopausal Women: A Randomised Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05348694
- Acronym / sponsor ID
- OsteoPreP / 2021-122HC
- Conditions
- Postmenopausal Osteopenia, Bone Loss, Age Related, Age-Related Sarcopenia, Glucose Metabolism Disorders, Age-related Cognitive Decline
- Keywords
- Postmenopausal bone loss, Probiotics, Volumetric bone mineral density, Short-chain fatty acids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Australian Catholic UniversityUniversity, hospital or other
- Collaborators
- Pendulum Therapeutics, Curtin University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- Apr 2025 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, e.g. 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 (n=80): 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pendulum WBF-038 | Active comparator | Dietary Supplement: Pendulum WBF-038Pendulum 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. |
| Pendulum Placebo | Placebo comparator | Dietary Supplement: Pendulum PlaceboPendulum Placebo containing Magnesium stearate - 1 capsule with the morning meal and 1 capsule with the evening meal for 12 months. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pendulum WBF-038All 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℃. | Dietary supplement | Pendulum WBF-038 |
| Pendulum PlaceboPendulum placebo capsules containing magnesium stearate | Dietary supplement | Pendulum Placebo |
Primary outcome
Total volumetric bone mineral density of the distal tibia
Time frame: 12 months
Percentage change in total volumetric bone density measured using high resolution peripheral quantitative computed tomography (HR-pQCT) of the distal tibia.
43 secondary outcomes
Bone mineral density of the lumbar spine
Time frame: 12 months
Bone mineral density of the hip
Time frame: 12 months
Tibia and radius trabecular bone volume
Time frame: 12 months
Tibia and radius cortical area
Time frame: 12 months
Tibia and radius cortical volumetric bone mineral density
Time frame: 12 months
Total volumetric bone mineral density of the distal radius
Time frame: 12 months
Serum C-terminal cross-linking telopeptide of type I collagen (ßCTX-I) - bone turnover marker
Time frame: 6 months and 12 months
Serum procollagen type 1 N-terminal propeptide (P1NP) - bone turnover marker
Time frame: 6 months and 12 months
Serum osteocalcin (OC) - bone turnover marker
Time frame: 6 months and 12 months
Short-chain fatty acids (SCFAs)
Time frame: 6 months, 12 months, and 2 weeks post intervention
16s rRNA genetic sequencing of the gut microbiota
Time frame: 6 months, 12 months, and 2 weeks post intervention
Fasting blood glucose
Time frame: 6 months and 12 months
Glycated haemoglobin (HbA1c)
Time frame: 6 months and 12 months
Lower leg muscle area
Time frame: 12 months
Lean body mass
Time frame: 12 months
Grip strength
Time frame: 6 months and 12 months
High-sensitivity C-reactive protein (hs-CRP)
Time frame: 6 months and 12 months
Regulatory T lymphocytes (Tregs)
Time frame: 12 months
Oral glucose tolerance test (OGTT)
Time frame: 6 months and 12 months
Muscle tissue glycogen content
Time frame: 6 months and 12 months
Muscle tissue triglyceride content
Time frame: 6 months and 12 months
Muscle tissue type 1 fibre composition
Time frame: 6 months and 12 months
Lipocalin2
Time frame: 6 months, 12 months, and 2 weeks post intervention
Cogstate One back Test Cognitive performance test
Time frame: 6 months and 12 months
Cogstate Groton Maze Learning Test Cognitive performance test
Time frame: 6 months and 12 months
Cogstate Continuous Paired Associate Learning Test Cognitive performance test
Time frame: 6 months and 12 months
Cogstate Social Emotional Cognition Test Cognitive performance test
Time frame: 6 months and 12 months
Depression, Anxiety and Stress Scale 21
Time frame: 6 months and 12 months
Gastrointestinal Symptom Rating Scale
Time frame: 6 months and 12 months
Plasma glucagon-like peptide 1
Time frame: 6 months and 12 months
Plasma peptide tyrosine-tyrosine
Time frame: 6 months and 12 months
Plasma adiponectin
Time frame: 6 months and 12 months
EuroQol Five Dimensions Quality of life Medical Outcome Survey
Time frame: 6 months and 12 months
Social Interaction Anxiety Scale
Time frame: 6 months and 12 months
The Warwick-Edinburgh Mental Wellbeing Scale
Time frame: 6 months and 12 months
Continuous blood glucose level monitoring for 10 days
Time frame: 6 months and 12 months
Fasting blood insulin
Time frame: 6 months and 12 months
Fat mass
Time frame: 12 months
Blood metabolomics
Time frame: 12 months
Office blood pressure
Time frame: 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Derived from this study: PubMed 39683612Turbic A, Vandenput L, Gandham A, Lorentzon M. Effects of Synbiotic Supplementation on Bone and Metabolic Health in Caucasian Postmenopausal Women: Rationale and Design of the OsteoPreP Trial. Nutrients. 2024 Dec 6;16(23):4219. doi: 10.3390/nu16234219.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Hawley, PhD principal investigator
Australian Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pendulum WBF-038 in people with Postmenopausal Osteopenia and Bone Loss, Age Related, run by Australian Catholic University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volumetric bone mineral density of the distal tibia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05348694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.