The effect of the natural mineral supplement Aquamin™ together with the short chain fructooligosaccaride Nutraflora® on bone health in post-menopausal wome
- Conditions
- OsteoporosisMusculoskeletal DiseasesOsteoporosis without pathological fracture
- Registration Number
- ISRCTN63118444
- Lead Sponsor
- Marigot Ltd (Ireland)
- Brief Summary
2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24453130 results 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35908118/ Associations of long chain polyunsaturated fatty acids with bone mineral density and bone turnover (added 01/08/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 300
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone mineral density: dual energy X-ray absorptiometry
- Secondary Outcome Measures
Name Time Method