Mechanisms by which fruit and vegetables influence postmenopausal bone health: a randomised controlled trial in a well-characterised population
| ISRCTN | ISRCTN86186352 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86186352 |
| Secondary identifying numbers | FSA project number: N05043 |
- Submission date
- 04/04/2007
- Registration date
- 30/04/2007
- Last edited
- 03/05/2011
- 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 Helen Macdonald
Scientific
Scientific
Osteoporosis Research Unit
Health Sciences Building
University of Aberdeen
Osteoporosis Research Unit
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
| Phone | +44 (0)1224 559001 |
|---|---|
| h.macdonald@abdn.ac.uk |
Study information
| Study design | Two year placebo-controlled randomised trial (double blind for potassium citrate arms and single blind for fruit and vegetable arm). |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study acronym | ADAFVT (Aberdeen Dietary Acidity, Fruit and Vegetable Trial) |
| Study objectives | To test whether fruit and vegetable intake reduces the acidity of a mixed diet and the requirement of bone for buffering, or provide other dietary components important for bone health. |
| Ethics approval(s) | Grampian Research Ethics Committee on 23/12/2002 (ref: 02/0053). |
| Health condition(s) or problem(s) studied | Low bone mass/risk of osteoporosis |
| Intervention | Minimisation criteria included key genotypes (vitamin D receptor genotype and Apolipoprotein E genotype, smoking and dietary acidity (calculated from protein to potassium ratio). Group A: potassium citrate equivalent to 900 g fruit and vegetables (55.5 mEq) Group B: potassium citrate equivalent to 300 g fruit and vegetables (18.5 mEq) Group C: 300 g of fruit and vegetables Group D: placebo Duration of treatment was two years for each treatment arm. |
| Intervention type | Other |
| Primary outcome measure | 1. Bone turnover markers: a. serum N-terminal Propeptide of type 1 collagen (P1NP), measured at baseline, 3, 6, 12, 18 and 24 months b. serum C-terminal telopeptide of type I collagen (CTX), measured at baseline, 3, 6, 12, 18 and 24 months c. urinary free Deoxypyridinoline cross-links (fDPD), measured at baseline, 3, 6, 12, 18 and 24 months; women also posted a fasted urine sample 6 to 8 weeks after the baseline visit |
| Secondary outcome measures | Bone mineral density change over two years measured by DEXA at baseline and 24 months. |
| Overall study start date | 01/03/2003 |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 260 |
| Key inclusion criteria | Women aged 55 years to 65 years who had taken part in a longitudinal study (Aberdeen Prospective Osteoporosis Screening Study). Includes: 1. Otherwise healthy women taking other types of diuretics (not potassium sparing diuretics) or hypertension tablets 2. Women on thyroxine treatment provided their thyroid function is stable (as assessed by free Thyroxine [T4] and Thyroid Stimulating Hormone [TSH] levels) and their dose had not changed in the year prior to study entry |
| Key exclusion criteria | 1. Suffering from severe disease 2. Malabsorption 3. Having difficulties swallowing tablets/capsules 4. Taking oral corticosteroids 5. On or past bisphosphonate treatment (more than a few weeks) 6. Taking Hormone Replacement Therapy (HRT) in the last six months 7. Less than five years past the menopause 8. Currently taking potassium-sparing diuretics 9. Osteoporosis diagnosed from Dual Energy X-ray Absorptiometry (DEXA) scan at baseline visit |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Osteoporosis Research Unit
Aberdeen
AB25 2ZD
United Kingdom
AB25 2ZD
United Kingdom
Sponsor information
Food Standards Agency (UK)
Government
Government
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom
| alisdair.wotherspoon@foodstandards.gsi.gov.uk | |
| Website | http://www.food.gov.uk |
"ROR" |
https://ror.org/05p20a626 |
Funders
Funder type
Government
Food Standards Agency (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Food Standards Agency, FSA
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2008 | Yes | No |
