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
Secondary identifying numbers	N/A

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Emeir Duffy
Scientific

University of Ulster
Coleraine Campus
Coleraine
BT52 1SA
United Kingdom

Phone	+44 (0)28 7032 3543
Email	em.duffy@ulster.ac.uk

Study information

Study design	Double-blind randomised placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Aquamin™, Nutraflora®
Primary outcome measure	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 study start date	01/01/2009
Completion date	31/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	3 x 100 per study arm (n = 300 in total)
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

Ireland
Northern Ireland
United Kingdom

Study participating centre

University of Ulster

Coleraine
BT52 1SA
United Kingdom

Sponsor information

Marigot Ltd (Ireland)
Industry

Strand Farm
Currabinny
Carrigaline
Cork
Ireland

Phone	+353 (0)21 437 8727
Email	coriena.murphy@marigot.ie
Website	http://www.marigot.ie
"ROR"	https://ror.org/05kmpn815

Funders

Funder type

Industry

Marigot Ltd (Ireland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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

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.