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OsteoPreP: Food Supplements for Postmenopausal Bone Health

NCT05348694 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-07-09

No results posted yet for this study

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.

Conditions

  • Postmenopausal Osteopenia
  • Bone Loss, Age Related
  • Age-Related Sarcopenia
  • Glucose Metabolism Disorders
  • Age-related Cognitive Decline

Interventions

DIETARY_SUPPLEMENT

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℃.

DIETARY_SUPPLEMENT

Pendulum Placebo

Pendulum placebo capsules containing magnesium stearate

Sponsors & Collaborators

  • Pendulum Therapeutics

    collaborator INDUSTRY

  • Curtin University

    collaborator OTHER

  • Australian Catholic University

    lead OTHER

Principal Investigators

  • John Hawley, PhD · Australian Catholic University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-03-28
Completion
2025-04-30

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05348694 on ClinicalTrials.gov