Servizio Comunitario di Informazione in materia di Ricerca e Sviluppo - CORDIS

Data set from main trial

A randomised, double blind, placebo controlled parallel multi-centre trial was conducted in The Netherlands (TNO Quality of Life, Zeist), Italy (INRAN, Rome) and France (INRA, Clermont-Ferrant) to investigate the effects of 1-year IF-enriched food/s consumption on bone mineral metabolism, bone density and on hormonal status in early postmenopausal women. 91 subjects completed the study in the Netherlands, 78 in Italy and 68 in France. Subjects were randomly allocated to a treatment group (IF+) and a control group (IF-). The IF+ group were administered a mean daily isoflavone intake of 110 mg.

The following SAS datasets are available:
- Data1 Screening Parameters
- Data2 Safety Parameters
- Data3 Body weight
- Data4 Adverse events
- Data5 Compliance
- Data6 3-Day dietary record
- Data7 Short Food Questionnaire continue variables
- Data7 Short Food Questionnaire consumption yes/no
- Data8 Physical Activity Questionnaire
- Data9 Climacteric Symptoms Questionnaire
- Data10 Bone mineral density (2 separate datasets combined)
- Data11 Bone markers in plasma
- Data12 Hormones in serum I
- Data12 Hormones in serum II
- Data13 Isoflavones in plasma
- Data14 Genotyping
- Data15 Bone markers in urine
- Data16 Isoflavones in urine nmol/24h
- Data16 Urine volume and equol nmol/L
- Data18 Vaginal smears

The data have been analysed and reported, but can be further be exploited to analyse the effects of isoflavone supplements and of background genetic and lifestyle factors on different biological parameters in post-menopausal women.

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