European Project on Nutrition in Elderly People

Aging Clinical Trial

— NU-AGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754012
• Other study ID #: 266486
• Status: Completed
• Phase: N/A
• First received: December 9, 2012
• Last updated: February 17, 2016
• Start date: April 2012
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1190
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Dietary Intervention
nutrient-rich diet and 10micrograms per day of Vitamin D (cholecalciferol) supplement from MCOHealth

Locations

Country	Name	City	State
France	Auvergne Research Center on Human Nutrition	Clermont-Ferrand
Italy	University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine	Bologna
Netherlands	University of Wageningen-Division of Human Nutrition	Wageningen
Poland	Warsaw University of Life Science SGGW-WULS-Department of Human Nutrition	Warsaw
United Kingdom	Department of Nurition-University of East Anglia	Norwich

Sponsors (2)

Lead Sponsor	Collaborator
University of Bologna	European Commission

Countries where clinical trial is conducted

France,  Italy,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Habitual Diet	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	No
Other	Genetic profiling	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	No
Other	General Health information	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Insulin sensitivity	Glucose, insulin and Hba1C will be measured on plasma pre and post dietary intervention	1 year	No
Secondary	Liver Function Status	ASAT, ALAT, GGT and alkaline phosphatase parameters will be measured on plasma samples pre and post dietary intervention.	1 year	No
Secondary	Hormonal Status	Leptin and adiponectin hormones will be measured on plasma samples pre and post dietary intervention	1 year	No
Secondary	Nutritional Status	The Nutritional status will be evaluated on plasma measuring vitamin B12 and folate concentrations.	1 year	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   NU-AGE project official website