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Mechanisms by which fruit and vegetables influence postmenopausal bone health: a randomised controlled trial in a well-characterised population

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN86186352
Enrollment
260
Registered
2007-04-30
Start date
2003-03-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low bone mass/risk of osteoporosis Musculoskeletal Diseases Osteoporosis

Interventions

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 c

Sponsors

Food Standards Agency (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Bone mineral density change over two years measured by DEXA at baseline and 24 months.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026