Contact information
Type
Scientific
Primary contact
Dr Emeir Duffy
ORCID ID
Contact details
University of Ulster
Coleraine Campus
Coleraine
BT52 1SA
United Kingdom
+44 (0)28 7032 3543
em.duffy@ulster.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Research Ethics Committee of the University of Ulster approved on the 21st July 2008 (ref: REC/08/0083)
Study design
Double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Aquamin™, Nutraflora®
Primary outcome measures
Bone mineral density: dual energy X-ray absorptiometry
Secondary outcome measures
1. Bone resorption and formation markers:
1.1. Serum CTx: ELISA
1.2. Urinary deoxypryridinoline cross-links: ELISA
1.3. Urinary CTx: ELISA
2. Serum intact osteocalcin: ELISA
3. Serum N-terminal midfragment OC: ELISA
4. Vitamin D: ELISA
5. Free calcium: ELISA
6. Parathyroid hormone: ELISA
7. Salivary Cortisol: ELISACalcium: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, UK)
8. Phosphate: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, UK)
9. Full Blood Profile: Sysmex full blood analyser
10. Electrolytes: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, UK)
11. Liver function:
11.1. Albumin: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, United)
11.2. Alanine transaminase: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, UK)
11.3. Gamma-glutamyltransferase: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, United)
11.4. Total bilirubin: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, United)
11.5. Alkaline Phosphatase: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, UK)
12. Total protein: Automated instrument (Instrumentation Laboratories UK Ltd, Warrington, UK)
13. Anthropometric measurements: height, weight, waist circumference, measured using standardised procedures
14. Blood pressure
15. Mean daily dietary intake (4-day diet diary)
16. Habitual dietary intake: Food Frequency Questionnaire
17. Exercise: Physical Activtiy Questionnaire
18. Sun Exposure: Questionnaire
Overall trial start date
01/01/2009
Overall trial end date
31/07/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
3 x 100 per study arm (n = 300 in total)
Participant 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
Recruitment start date
01/01/2009
Recruitment end date
31/07/2011
Locations
Countries of recruitment
Ireland
Trial participating centre
University of Ulster
Coleraine
BT52 1SA
United Kingdom
Sponsor information
Organisation
Marigot Ltd (Ireland)
Sponsor details
Strand Farm
Currabinny
Carrigaline
Cork
Ireland
+353 (0)21 437 8727
coriena.murphy@marigot.ie
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Marigot Ltd (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24453130
Publication citations
-
Results
Slevin MM, Allsopp PJ, Magee PJ, Bonham MP, Naughton VR, Strain JJ, Duffy ME, Wallace JM, Mc Sorley EM, Supplementation with calcium and short-chain fructo-oligosaccharides affects markers of bone turnover but not bone mineral density in postmenopausal women., J. Nutr., 2014, 144, 3, 297-304, doi: 10.3945/jn.113.188144.