NCT05348694

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

July 9, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

April 18, 2022

Last Update Submit

July 7, 2024

Conditions

Postmenopausal OsteopeniaBone Loss, Age RelatedAge-Related SarcopeniaGlucose Metabolism DisordersAge-related Cognitive Decline

Keywords

Postmenopausal bone lossProbioticsVolumetric bone mineral densityShort-chain fatty acids

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (43)

  • Bone mineral density of the lumbar spine

    12 months

  • Bone mineral density of the hip

    12 months

  • Tibia and radius trabecular bone volume

    12 months

  • Tibia and radius cortical area

    12 months

  • Tibia and radius cortical volumetric bone mineral density

    12 months

  • +38 more secondary outcomes

Study Arms (2)

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.

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.

Dietary Supplement: Pendulum Placebo

Interventions

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 WBF-038
Pendulum PlaceboDIETARY_SUPPLEMENT

Pendulum placebo capsules containing magnesium stearate

Pendulum Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOsteoPreP is an intervention trial for the prevention of bone loss in early post-menopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Unwilling to cease taking other probiotic or prebiotic supplements (current use)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Australian Catholic University

Melbourne, Victoria, 3000, Australia

Location

Related Publications (1)

  • 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.

    PMID: 39683612DERIVED

MeSH Terms

Conditions

OsteoporosisGlucose Metabolism DisordersOsteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • John Hawley, PhD

    Australian Catholic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized placebo-controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 27, 2022

Study Start

May 1, 2022

Primary Completion

March 28, 2024

Study Completion

April 1, 2025

Last Updated

July 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)