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Screening and recruitment procedure of late-middle aged and older subjects: the ZENITH study
A Polito1, N Meunier, M Andriollo-Sanchez
1National Institute for Food and Nutrition Research, Human Nutrition Unit, Rome, Italy. polito@inran.it
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.