European Project on Nutrition in Elderly People (NU-AGE)

February 17, 2016 updated by: Claudio Franceschi, University of Bologna

New Dietary Strategies Addressing the Specific Needs of Elderly Population for an Healthy Aging in Europe

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63009
        • Auvergne Research Center on Human Nutrition
  • Italy
      • Bologna, Italy, 40126
        • University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine
  • Netherlands
      • Wageningen, Netherlands, 6703 HD
        • University of Wageningen-Division of Human Nutrition
  • Poland
      • Warsaw, Poland, 02-776
        • Warsaw University of Life Science SGGW-WULS-Department of Human Nutrition
  • United Kingdom
      • Norwich, United Kingdom, NR4 7TJ
        • Department of Nurition-University of East Anglia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 79 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 65-79 years old.
  • Free of clinically diagnosed overt disease for at least 2 years.
  • Free-living, independent.

Exclusion Criteria:

  • <65 or > 79 years old.
  • Overt disease such as aggressive cancer or dementia.
  • Unstable organ failure or organ failure necessitating a special diet.
  • Heart failure.
  • Renal failure.
  • Respiratory failure.
  • Liver failure.
  • Type 1 diabetes mellitus.
  • Chronic use of corticosteroids.
  • Recent (previous 2 months) use of antibiotics.
  • Recent (previous 3 months) change to habitual medication (e.g statins and thyroxine) use
  • Presence of food allergy/intolerance or disease necessitating a special diet.
  • Malnutrition, as diagnosed by body mass index < 18.5 kg/m2.
  • Body weight loss of >10% BW within 6 months.
  • Presence of frailty (as assessed by the presence of at least three out of five criteria according to Fried et al., 2001: unintentional weight loss, self-reported exhaustion, weakness (grip strength), slow walking speed, and low physical activity).
  • Individual unable to give informed consent.
  • Volunteers showing previously unrecognized illness will also be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary Intervention
This group will follow for a year the NU-AGE whole diet approach elderly-specific and will be supplemented with 10micrograms per day of Vitamin D (cholecalciferol) from MCOHealth.
Dietary supplement: Dietary Intervention
nutrient-rich diet and 10micrograms per day of Vitamin D (cholecalciferol) supplement from MCOHealth
Other Names:
  • NU-AGE diet
  • NU-AGE whole diet approach
No Intervention: Control Group
This group will follow the habitual diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory Response
Time Frame: 1 year

Reduction of inflammatory markers after one-year of NU-AGE dietary intervention in elderly.

Measures of inflammatory status and immune health will be evaluated on plasma: C-reactive protein (hsCRP) IL-1Beta, IL-12, INF gamma, IL-6, sIL-6R, IL-1RA, TNFalpha, IL-17, IL-8, IL-10, TGF-beta1, positivity for HCMV.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Status
Time Frame: 1 year

The following standardized questionnaires will be administered to volunteers pre and post dietary intervention to evaluate cognitive function:

  1. CERAD Neuropsychological Assessment Battery
  2. Domain Specific Tests (GDS, Babcock story Recall, Trail Making Test)
1 year
Cardiovascular Health Status
Time Frame: 1 year
Evaluation of blood pressure and measure of lipid profile (triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol) pre and post dietary intervention on plasma.
1 year
Insulin sensitivity
Time Frame: 1 year
Glucose, insulin and Hba1C will be measured on plasma pre and post dietary intervention
1 year
Liver Function Status
Time Frame: 1 year
ASAT, ALAT, GGT and alkaline phosphatase parameters will be measured on plasma samples pre and post dietary intervention.
1 year
Hormonal Status
Time Frame: 1 year
Leptin and adiponectin hormones will be measured on plasma samples pre and post dietary intervention
1 year
Nutritional Status
Time Frame: 1 year
The Nutritional status will be evaluated on plasma measuring vitamin B12 and folate concentrations.
1 year
Digestive Health Status
Time Frame: 1 year
Questionnaire to assess bowel function, gastrointestinal disturbances and evacuation frequency will be administered to participants pre and post dietary intervention.
1 year
Bone Health Status
Time Frame: 1 year
All participants, pre and post dietary intervention, will undergone DXA exam to evaluate bone mineral density, also 25-OH vitamin D, parathyroid hormone will be measured on plasma samples.
1 year
Physical Functioning
Time Frame: 1 year

The following standardized questionnaires will be administered to volunteers pre and post dietary intervention to evaluate physical function:

  1. SPPB
  2. Hand grip test
  3. Gait Speed Test
  4. ADL, IADL
  5. PASE
1 year
Changes on Cellular and Molecular mechanisms after diet: Immunological Status
Time Frame: 1 year

On a subgroup of 125subjects (pre and post diet), the following of additional analyses on plasma will be performed to evaluate the immunological status of participants:

  1. Expression and responsiveness of Toll-like receptors, measured as production of downstream cytokines (IFN-a, IFN-b, IFN-y, IL12p40, IL12p70, SOCS3)
  2. Expression of co-stimulatory molecules (CD1, MHC Class II, CD40, CD80, CD86, CD152, CD154, DC1/DC2)
1 year
Changes on Cellular and Molecular mechanisms after diet: Epigenetic signature
Time Frame: 1 year
On a subgroup of 120 subjects (pre and post diet), the epigenetic signature will be evaluated through methylation assay on isolated PBMC.
1 year
Changes on Cellular and Molecular mechanisms after diet: biochemical modifications
Time Frame: 1 year
On a subgroup of 120 subjects (pre and post diet), proteasome and immunoproteasome composition and activity will be measured on proteins from isolated PBMC.
1 year
Transcriptomics
Time Frame: 1 year
On a subgroup of 120 subjects (pre and post diet) a transcriptomics analysis will be performed on mRNA from isolated PBMC by high throughput technologies "omics".
1 year
Metabolomics
Time Frame: 1 year
On a subgroup of 120 subjects (pre and post diet) a the metabolic profile will be performed on urine and plasma/serum by high throughput technologies "omics".
1 year
Metagenomics
Time Frame: 1 year
On a subgroup of 120 subjects (pre and post diet) the functional and compositional analysis of the microbiota will be assessed on feces by high throughput technologies "omics".
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Habitual Diet
Time Frame: 4 months
Over the course of the 1-year intervention period assessment of habitual diet, will be conducted by repeated the 7 days nutritional diary administered in person (month 1 and 12) and 3 days nutritional diary administered at interim time points (months 4-8) by telephone.
4 months
Genetic profiling
Time Frame: Time 0
The genetic profiling of genes involved in inflammageing will be analyzed (only before diet) in order to assess genotype-phenotype and genotype-diet phenotype associations.
Time 0
General Health information
Time Frame: 1 year
Information will be collected at month 1 and 12 on smoking status, health status, physical activity levels, alcohol consumption and medication and supplement use, so that these parameters can be added to all statistical analysis models as confounders
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Collaborators

European Commission

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

December 9, 2012

First Submitted That Met QC Criteria

December 17, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 266486

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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