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The four participating partners involved in the recruitment of volunteers are
INRA (Clermont-Ferrand, France)
UJF (Grenoble, France)
UU (Coleraine, Northern Ireland, UK)
INRAN (Rome, Italy)
The four partners have obtained agreements from their local Ethical Committees before starting the trials.
In order to call for volunteers'participation, the aim and progression of the study have been explained throughout local media - television, radio, newspapers.
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The six months extension, requested to the European Commission in order to fulfill the whole zenith project commitments, is now quite achieved (end August 31th, 2005).
The biological and psychological measurements are done. Statistical analyses for the biological and psychological parameters was performed. The last meeting for all zenith partners took place in Cork (March 2005).
The scientific results of the zenith project begins to be available.
The main preliminary results are as follow:
- Subjects characteristics at baseline: Population of zenith study is homogenous. The compliance for whole study is very satisfacory (females 99.2%, males 99.3%). Administration of Zn at nutritional doses (15 or 30 mg/d) is well tolerated. Few adverse effects have been observed (<9%). In most cases, it was headache (3.4%). Middle aged females (9%) show a 5 fold higher placebo effect compared to older females and middle-aged males (1.8%).
- Effect of 6 months zinc supplementation on micronutrient status:Zinc supplementation has no effect on serum copper and iron levels or on transferrine saturation. In contrast, serum ferritin levels increase significantly with zinc supplementation. These preliminary data indicate that nutritional zinc supplementation has no adverse effect on micronutrient status. Consistent with the reported compliance data, serum zinc increased significantly following Zn administration.
- Effect of 6 months zinc supplementation on oxidative stress: Preliminary results show that, wathever the dose (15 or 30 mg Zn/day), Zn supplementation during 6 months, has no significant effect on oxidative stress parameters.
- Effect of 6 months zinc supplementation on bone markers: Significant increase in bone specific phosphatase alkaline (B-sALP) is observed with 30 mg Zn/d. B-sALP is Zn dependent and involved in bone formation. This increase without change in bone resorption markers tends thus to indicate an improvement of bone status with Zn supplementation.
Other results on Zenith subjects characteristics at baseline should be available in a special issue of Eur J Clin Nutr (November 2005). Articles on the effetc of zinc supplementation have already been published and other papers will be written in the next year.
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2002 INRA All Rights reserved
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