The effect of the natural mineral supplement Aquamin™ together with the short chain fructooligosaccaride Nutraflora® on bone health in post-menopausal women
| ISRCTN | ISRCTN63118444 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63118444 |
| Protocol serial number | N/A |
| Sponsor | Marigot Ltd (Ireland) |
| Funder | Marigot Ltd (Ireland) |
- Submission date
- 12/08/2009
- Registration date
- 02/10/2009
- Last edited
- 01/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University of Ulster
Coleraine Campus
Coleraine
BT52 1SA
United Kingdom
| Phone | +44 (0)28 7032 3543 |
|---|---|
| em.duffy@ulster.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effect of the mineral supplement Aquamin™ together with the short chain fructooligosaccaride Nutraflora® on bone mineral density and bone turnover markers in post-menopausal women: a double-blind, randomised, placebo-controlled trial |
| Study objectives | Osteoporosis and low bone mass is becoming a major public health problem with post-menopausal women being at the highest risk. Osteoporosis is a disease characterised by low bone mineral density (BMD), where the structure of bone deteriorates, making it more susceptible to fractures, especially in the spine, hip and wrist. A recent animal study has shown the mineral supplement Aquamin™ to enhance bone mineral density. Furthermore, there is also evidence that short-chain fructooligosaccharide (Nutraflora®) supplementation enhances bone mineral density in rats. This study sets out to investigate the effect of supplementation of Aquamin™ together with the short chain fructooligosaccaride Nutraflora® on bone health using bone mineral density and bone turnover markers as indicators of bone health in post-menopausal women. |
| Ethics approval(s) | Research Ethics Committee of the University of Ulster approved on the 21st July 2008 (ref: REC/08/0083) |
| Health condition(s) or problem(s) studied | Osteoporosis |
| Intervention | Each treatment is incorporated into chocolate chews and will be supplemented with 2 x chocolate flavoured chews. Individuals are supplemented per day for 2 years. Treatment 1: Placebo (maltrodextrin) Treatment 2: Aquamin™ (1800 mg/d) alone Treatment 3: Aquamin™ (1800 mg/d) with Nutraflora® (3.6 g/d) |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Aquamin™, Nutraflora® |
| Primary outcome measure(s) |
Bone mineral density: dual energy X-ray absorptiometry |
| Key secondary outcome measure(s) |
1. Bone resorption and formation markers: |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 300 |
| Total final enrolment | 300 |
| Key inclusion criteria | 1. Apparently healthy post-menopausal female volunteers (defined as having no menstrual period, bleeding or spotting during 1 year prior to enrolment) 2. Aged 48 - 75 years old 3. Weight less than 136 kg (DEXA [dual energy x-ray absorptiometry] limit 136 kg) 4. Community dwelling and fully mobile, with hormone implants (if used) removed at least one year prior to randomisation |
| Key exclusion criteria | 1. Osteoporotic bone density (T-score less than -2.5) 2. Corticosteroid medications during the previous 6 months 3. History/presence of chronic renal, hepatic, gastrointestinal disease or traumatic lumbar compression fracture 4. Evidence of collapsed or focal vertebral sclerosis 5. Menopause before the age of 40 years 6. Bone diseases or other condition known to affect bone status 7. Treatment with specific therapy for osteoporosis 8. Uncontrolled hypertension or heart failure, renal calculi 9. Volunteers should not have used any prescribed medication known to affect bone status 10. Use of dietary supplements containing calcium and vitamin D three months prior to the study |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
- Ireland
Study participating centre
BT52 1SA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2014 | Yes | No | |
| Other publications | Associations of long chain polyunsaturated fatty acids with bone mineral density and bone turnover | 30/07/2022 | 01/08/2022 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/08/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the main results reference.
