Screening and recruitment procedure of late-middle aged and older subjects: the ZENITH study.
OBJECTIVE
To report the rational, design, recruitment, baseline characteristics and preliminary overview of volunteers in the ZENITH study.


METHODS
A multicentre prospective intervention study employing a randomised double-blind design.


METHODS
Clermont-Ferrand, Theix (France), Coleraine (Northern Ireland), Grenoble (France), Rome (Italy).


METHODS
Healthy men and women middle-aged (55-70 y) and older volunteers (70-87 y).


METHODS
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.
Polito
A
A
National Institute for Food and Nutrition Research, Human Nutrition Unit, Rome, Italy. polito@inran.it
Meunier
N
N
Andriollo-Sanchez
M
M
Catasta
G
G
Azzini
E
E
Simpson
E E A
EE
O'Connor
J M
JM
Roussel
A M
AM
Ferry
M
M
Coudray
C
C
Maiani
G
G
D000368:Aged; D000375:Aging / Q000502:physiology*; D000886:Anthropometry / Q000379:methods; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006304:Health Status; D006801:Humans; D008019:Life Style; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D009749:Nutrition Surveys; D018579:Patient Selection; D010808:Physical Examination / Q000379:methods; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012016:Reference Values; D012107:Research Design