European Project on Nutrition in Elderly People

Study Overview
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Brief Summary
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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.

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

Conditions
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Aging

Intervention / Treatment
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* Dietary Supplement: Dietary Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Intervention<br>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<br>* nutrient-rich diet and 10micrograms per day of Vitamin D (cholecalciferol) supplement from MCOHealth<br>* Other names: NU-AGE whole diet approach;|
| No Intervention: Control Group<br>This group will follow the habitual diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Response | 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 | 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) | 1 year | 
| Cardiovascular Health Status | 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 | Glucose, insulin and Hba1C will be measured on plasma pre and post dietary intervention | 1 year | 
| Liver Function Status | ASAT, ALAT, GGT and alkaline phosphatase parameters will be measured on plasma samples pre and post dietary intervention. | 1 year | 
| Hormonal Status | Leptin and adiponectin hormones will be measured on plasma samples pre and post dietary intervention | 1 year | 
| Nutritional Status | The Nutritional status will be evaluated on plasma measuring vitamin B12 and folate concentrations. | 1 year | 
| Digestive Health Status | 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 | 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 | 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 | 1 year | 
| Changes on Cellular and Molecular mechanisms after diet: Immunological Status | 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) | 1 year | 
| Changes on Cellular and Molecular mechanisms after diet: Epigenetic signature | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Dietary intervention, Aging, Inflammation, Elderly, Europe