Propionate and bone health
| ISRCTN | ISRCTN10449148 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10449148 |
| IRAS number | 307502 |
| Secondary identifying numbers | 21HH7302 |
- Submission date
- 05/03/2025
- Registration date
- 09/04/2025
- Last edited
- 09/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoporotic fractures are a major health issue in the UK, with over 500,000 cases each year. Postmenopausal women are at a higher risk due to the impact of menopause on bone health. This study aims to test a new dietary supplement called inulin-propionate ester (IPE) to see if it can improve bone health and prevent fractures in postmenopausal women.
Who can participate?
Postmenopausal women aged 50-75 years.
What does the study involve?
Participants will attend four visits at the NIHR Imperial Clinical Research Facility at Hammersmith Hospital. These visits include health screenings, blood and urine tests, and dietary assessments. Participants will take either the IPE supplement or a control substance daily for 8 weeks. Blood and stool samples will be collected regularly to measure health markers.
What are the possible benefits and risks of participating?
Participants may benefit from learning more about their health. However, there are some risks, such as mild discomfort from blood tests and potential side effects from the supplement, like bloating and flatulence. Any health issues discovered during the study will be communicated to the participant and their GP.
Where is the study run from?
The study is run from the NIHR Imperial Clinical Research Facility at Hammersmith Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2021 to December 2026
Who is funding the study?
The study is funded by the Rosetrees Trust and the Stoneygate Trust (UK)
Who is the main contact?
Dr Edward Chambers, e.chambers@imperial.ac.uk
Contact information
Public, Scientific, Principal Investigator
Imperial College London
London
W12 0NN
United Kingdom
 ORCID ID |
0000-0001-7074-1312 |
|---|---|
| Phone | +44 20 3313 8070 |
| e.chambers@imperial.ac.uk |
Study information
| Study design | Randomized parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | 46950 Participant Information Sheet - Version 3 - 300522.pdf |
| Scientific title | Increasing gut-derived propionate to improve bone health in postmenopausal women |
| Study acronym | BOPRO |
| Study objectives | Dietary propionate supplementation with inulin-propionate ester (IPE) will improve bone turnover makers in postmenopausal women |
| Ethics approval(s) |
Approved 06/06/2022, London - South East (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048222; londonsoutheast.rec@hra.nhs.uk), ref: 21/LO/0913 |
| Health condition(s) or problem(s) studied | Prevention of osteoporotic fractures in postmenopausal women |
| Intervention | Inulin-propionate ester (Intervention): 10 g/day for 8 weeks. Incorporated into habitual diet. Cellulose (Control): 10 g/day for 8 weeks. Incorporated into habitual diet Randomisation will be conducted using https://www.sealedenvelope.com/ |
| Intervention type | Supplement |
| Primary outcome measure | 1. Carboxy-terminal telopeptide of type I collagen (CTX-I) is measured at baseline, week 2, and week 8 in fasting and postprandial blood samples 2. N-telopeptide of type I collagen (NTX-I) is measured at baseline, week 2, and week 8 in fasting and postprandial blood samples 3. N-terminal propeptide of type I procollagen (PINP) is measured at baseline, week 2, and week 8 in fasting and postprandial blood samples 4. Osteocalcin is measured at baseline, week 2, and week 8 in fasting and postprandial blood samples 5. Bone specific alkaline phosphatase (BAP) is measured at baseline, week 2, and week 8 in fasting and postprandial blood samples 6. N-telopeptide of type I collagen (NTX-I) is measured at baseline, week 2, and week 8 in urine samples |
| Secondary outcome measures | 1. Short chain fatty acids (SCFA) are measured in blood samples and stool samples at baseline and week 8 2. Glucose homeostasis is measured using blood glucose, insulin, HbA1c, and insulin-like growth factor 1 (IGF-1) at baseline and week 8 3. Immune function is measured using inflammatory cytokines and immune phenotyping of peripheral blood mononuclear cells (PBMCs) at baseline and week 8 4. Gut barrier function is measured using lipopolysaccharide (LPS) in blood samples and calprotectin and zonulin in stool samples at baseline and week 8 5. Calcium and Vitamin D metabolism is measured using parathyroid hormone and Vitamin D 25-hydroxy in blood samples at baseline and week 8 |
| Overall study start date | 09/11/2021 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Upper age limit | 75 Years |
| Sex | Female |
| Target number of participants | 28 |
| Key inclusion criteria | 1. Post-menopausal females (>5 years post-menopause) 2. Healthy non-obese volunteers (body mass index (BMI) of 20-30 kg/m²) 3. Age between 50-75 years (inclusive) 4. Non-diabetic (HbA1c <48 mmol/mol) |
| Key exclusion criteria | 1. Weight change of ≥ 3kg in the preceding 2 months 2. Current smokers 3. Substance abuse 4. Excess alcohol intake 5. Cardiovascular disease 6. Cancer 7. Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome 8. Kidney disease 9.Pancreatitis 10. Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones |
| Date of first enrolment | 01/06/2025 |
| Date of final enrolment | 31/05/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Du Cane Rd
Shepherd's Bush
London
W12 0HS
United Kingdom
Sponsor information
University/education
Research Governance and Integrity Team
Imperial College London and Imperial College Healthcare NHS Trust
Room 215, Level 2, Medical School Building
Norfolk Place
London
W2 1PG
England
United Kingdom
| Phone | +44 207 594 1862 |
|---|---|
| rgit@imperial.ac.uk | |
| Website | https://www.imperial.ac.uk |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Teresa Rosenbaum Golden Charitable Trust, Rosetrees
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 01/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The findings of the research will be published in an open-access, peer-reviewed journal. In addition, we will be collaborating with patient groups and professional groups to disseminate the findings via multiple media channels such as patient association publications, print and broadcast media. All data will be anonymised prior to publication. |
| IPD sharing plan | The datasets generated during and/or analysed the current study will be available upon request from Dr Edward Chambers e.chambers@imperial.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 30/05/2022 | 06/03/2025 | No | Yes |
| Protocol file | version 1 | 09/11/2021 | 06/03/2025 | No | No |
Additional files
Editorial Notes
05/03/2025: Trial's existence confirmed by NHS HRA.
