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

University of Bologna

Status: Completed

Conditions: Aging

Treatments: Dietary Supplement: Dietary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01754012

266486

Details and patient eligibility

About

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.

Enrollment: 1,190 patients

Sex: All

Ages: 65 to 79 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,190 participants in 2 patient groups

Dietary Intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Dietary Intervention

Control Group

No Intervention group

Description:

This group will follow the habitual diet.