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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Claudio Franceschi, University of Bologna
ClinicalTrials.gov Identifier:
NCT01754012
First received: December 9, 2012
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Aging
Dietary Supplement: Dietary Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: New Dietary Strategies Addressing the Specific Needs of Elderly Population for an Healthy Aging in Europe

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • Inflammatory Response [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Cognitive Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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)

  • Cardiovascular Health Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Evaluation of blood pressure and measure of lipid profile (triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol) pre and post dietary intervention on plasma.

  • Insulin sensitivity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Glucose, insulin and Hba1C will be measured on plasma pre and post dietary intervention

  • Liver Function Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    ASAT, ALAT, GGT and alkaline phosphatase parameters will be measured on plasma samples pre and post dietary intervention.

  • Hormonal Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Leptin and adiponectin hormones will be measured on plasma samples pre and post dietary intervention

  • Nutritional Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The Nutritional status will be evaluated on plasma measuring vitamin B12 and folate concentrations.

  • Digestive Health Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Questionnaire to assess bowel function, gastrointestinal disturbances and evacuation frequency will be administered to participants pre and post dietary intervention.

  • Bone Health Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Physical Functioning [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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

  • Changes on Cellular and Molecular mechanisms after diet: Immunological Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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)

  • Changes on Cellular and Molecular mechanisms after diet: Epigenetic signature [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    On a subgroup of 120 subjects (pre and post diet), the epigenetic signature will be evaluated through methylation assay on isolated PBMC.

  • Changes on Cellular and Molecular mechanisms after diet: biochemical modifications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    On a subgroup of 120 subjects (pre and post diet), proteasome and immunoproteasome composition and activity will be measured on proteins from isolated PBMC.

  • Transcriptomics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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".

  • Metabolomics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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".

  • Metagenomics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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".


Other Outcome Measures:
  • Habitual Diet [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Genetic profiling [ Time Frame: Time 0 ] [ Designated as safety issue: No ]
    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.

  • General Health information [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1250
Study Start Date: April 2012
Estimated Study Completion Date: January 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   65 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754012

Locations
France
Auvergne Research Center on Human Nutrition
Clermont-Ferrand, France, 63009
Italy
University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine
Bologna, Italy, 40126
Netherlands
University of Wageningen-Division of Human Nutrition
Wageningen, Netherlands, 6703 HD
Poland
Warsaw University of Life Science SGGW-WULS-Department of Human Nutrition
Warsaw, Poland, 02-776
United Kingdom
Department of Nurition-University of East Anglia
Norwich, United Kingdom, NR4 7TJ
Sponsors and Collaborators
University of Bologna
European Commission
Investigators
Principal Investigator: Claudio Franceschi, MD University of Bologna
  More Information

Additional Information:
No publications provided by University of Bologna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Claudio Franceschi, Professor, University of Bologna
ClinicalTrials.gov Identifier: NCT01754012     History of Changes
Other Study ID Numbers: 266486
Study First Received: December 9, 2012
Last Updated: June 18, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by University of Bologna:
Nutrition
Dietary intervention
Aging
Inflammation
Elderly
Europe

ClinicalTrials.gov processed this record on August 21, 2014