Abstract
Objective:
To report the rational, design, recruitment, baseline characteristics and preliminary overview of volunteers in the ZENITH study.
Design:
A multicentre prospective intervention study employing a randomised double-blind design.
Setting:
Clermont-Ferrand, Theix (France), Coleraine (Northern Ireland), Grenoble (France), Rome (Italy).
Participants:
Healthy men and women middle-aged (55–70 y) and older volunteers (70–87 y).
Interventions:
At baseline (prior to zinc (Zn) supplementation), all volunteers underwent a full clinical examination, anthropometric measurements, health and lifestyle questionnaire, Mini Mental State Examination, Geriatric Depression Scale, and biochemistry profile.
Results:
In total, 842 volunteers (378 men and 464 women) were invited to take part in the study. A total of 49% of these volunteers were excluded on the basis of inclusion/exclusion criteria. In total, 433 participants were admitted to the Zn supplementation for 6 months. During this period, about 10% of volunteers dropped out from the study.
Conclusions:
A total of 387 subjects (197 male and 190 female subjects) successfully completed the supplementation phase of the ZENITH study.
Sponsorship:
The ZENITH study is supported by the European Commission ‘Quality of Life and Management of Living Resources’ Fifth Framework Programme, Contract No: QLK1-CT-2001-00168.
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Acknowledgements
We acknowledge all volunteers for their cooperation. INRAN thank the municipal administrators of 11° and 17° municipalities in Rome, the Director of Health Centre of ASL RME and the family doctors for their invaluable support in the recruitment of volunteers and in particular Dr Palmira Leone.
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Guarantor: G Maiani.
Contributors: AP is the scientific advisor responsible for INRAN and wrote the paper; NM, MAS, EEAS were responsible for recruitment in each centre; GC was involved in the Italian recruitment of volunteers; EA performed data collection for biochemistry profile; JMO, AMR, MF, GM are the partners’ leaders; CC is the ZENITH project Coordinator. All authors have contributed to finalisation of the manuscript.
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Polito, A., Meunier, N., Andriollo-Sanchez, M. et al. Screening and recruitment procedure of late-middle aged and older subjects: the ZENITH study. Eur J Clin Nutr 59 (Suppl 2), S8–S12 (2005). https://doi.org/10.1038/sj.ejcn.1602287
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DOI: https://doi.org/10.1038/sj.ejcn.1602287
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