Skip to main content
OpenTrials
Completed

NCT Number: NCT01754012

European Project on Nutrition in Elderly People

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aging Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auvergne Research Center on Human Nutrition, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dietary intervention

Dietary Supplement

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

Other names: NU-AGE diet, NU-AGE whole diet approach

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cognitive Status

    Time frame: 1 year

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

    • CERAD Neuropsychological Assessment Battery
    • Domain Specific Tests (GDS, Babcock story Recall, Trail Making Test)

  2. 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.

  3. Insulin sensitivity

    Time frame: 1 year

    Glucose, insulin and Hba1C will be measured on plasma pre and post dietary intervention

  4. 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.

  5. Hormonal Status

    Time frame: 1 year

    Leptin and adiponectin hormones will be measured on plasma samples pre and post dietary intervention

  6. Nutritional Status

    Time frame: 1 year

    The Nutritional status will be evaluated on plasma measuring vitamin B12 and folate concentrations.

  7. 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.

  8. 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.

  9. Physical Functioning

    Time frame: 1 year

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

    • SPPB
    • Hand grip test
    • Gait Speed Test
    • ADL, IADL
    • PASE

  10. 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:

    • Expression and responsiveness of Toll-like receptors, measured as production of downstream cytokines (IFN-a, IFN-b, IFN-y, IL12p40, IL12p70, SOCS3)
    • Expression of co-stimulatory molecules (CD1, MHC Class II, CD40, CD80, CD86, CD152, CD154, DC1/DC2)

  11. 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.

  12. 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.

  13. 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".

  14. 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".

  15. 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".

Other outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Collaborators

  • European Commission

Registry information

Official study title

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

Acronym: NU-AGE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 21, 2012
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.