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European Project on Nutrition in Elderly People

NCT01754012 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1190

Last updated 2016-02-18

No results posted yet for this study

Summary

NU-AGE is a large multidisciplinary consortium (31 partners, from 17 EU countries) involving nutritionists, bio-gerontologists, immunologists and molecular biologists from the most prestigious institutions in Europe, 5 large food industries, 8 traditional food companies and 1 biotech SME, SPES GEIE and CIAA, covering the SME Food Industrial Associations of 13 European countries and the European Confederation the food and drink industry. NU-AGE aims are: 1. to counteract the physical/cognitive decline occurring in the elderly as a consequence of the progressive alteration of different organs/systems (immune and cardiovascular systems, bone, brain, muscle and intestine) by one year elderly-tailored whole diet intervention on 1250 healthy elderly men and women aged 65-79 years (half diet, half control) from 5 different EU regions; 2. to assess the effect of the newly designed food pyramid specific for 65+ EU citizens on the different organs/systems using a large set of biomarkers related to nutrition and aging, with particular attention to the low grade, chronic, systemic inflammatory status named inflammageing, a major risk factor for common age-related diseases; 3. to perform in a subgroup of 120 subjects in depth studies and high throughput "omics" to identify cellular/molecular targets/mechanisms responsible for whole diet effect; 4. to perform genetic and epigenetic studies to assess the role of individual variability on the response to diet; 5. to adopt an integrative comprehensive approach (systems biology) to analyze the whole set of data. The results of dietary intervention will be used to develop elderly-tailored prototypes of functional foods and to improve traditional foods. The research activity will be accompanied and followed by a strong activity of dissemination and industrial exploitation to support EU strategies on nutritional recommendations, thus contributing to the implementation of legislation related to nutritional and health claims for elderly in Europe.

Conditions

  • Aging

Interventions

DIETARY_SUPPLEMENT

Dietary Intervention

nutrient-rich diet and 10micrograms per day of Vitamin D (cholecalciferol) supplement from MCOHealth

Sponsors & Collaborators

Principal Investigators

  • Claudio Franceschi, MD · University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • France
  • Italy
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01754012 on ClinicalTrials.gov