NU-AGE: European Project on Nutrition in Elderly People

Sponsor

University of Bologna (Other)

Overall Status

Completed

CT.gov ID

NCT01754012

Collaborator

European Commission (Other)

1,190

Enrollment

Locations

Arms

Duration (Months)

238

Patients Per Site

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aging	Dietary Supplement: Dietary Intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1190 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Inflammatory Response [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 Outcome Measures

Cognitive Status [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)
Cardiovascular Health Status [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.
Insulin sensitivity [1 year]
Glucose, insulin and Hba1C will be measured on plasma pre and post dietary intervention
Liver Function Status [1 year]
ASAT, ALAT, GGT and alkaline phosphatase parameters will be measured on plasma samples pre and post dietary intervention.
Hormonal Status [1 year]
Leptin and adiponectin hormones will be measured on plasma samples pre and post dietary intervention
Nutritional Status [1 year]
The Nutritional status will be evaluated on plasma measuring vitamin B12 and folate concentrations.
Digestive Health Status [1 year]
Questionnaire to assess bowel function, gastrointestinal disturbances and evacuation frequency will be administered to participants pre and post dietary intervention.
Bone Health Status [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.
Physical Functioning [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
Changes on Cellular and Molecular mechanisms after diet: Immunological Status [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)
Changes on Cellular and Molecular mechanisms after diet: Epigenetic signature [1 year]
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 [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.
Transcriptomics [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".
Metabolomics [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".
Metagenomics [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 Outcome Measures

Habitual Diet [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.
Genetic profiling [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.
General Health information [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

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