Condition category
Musculoskeletal Diseases
Date applied
12/08/2009
Date assigned
02/10/2009
Last edited
15/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.marigot.ie

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

  1. 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.

Additional files

Editorial Notes