An interventional study of Dietary Intervention in Aging, sponsored by University of Bologna. Completed at 5 sites in 5 countries. Open to participants aged 65 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-18.
Sponsored by University of Bologna · Not applicable, Interventional, and Prevention
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.
University of Bologna is the lead sponsor of 153 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
This group will follow the habitual diet.
nutrient-rich diet and 10micrograms per day of Vitamin D (cholecalciferol) supplement from MCOHealth
Also known as: NU-AGE diet, NU-AGE whole diet approach
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.
Time frame: 1 year
Cognitive Status
The following standardized questionnaires will be administered to volunteers pre and post dietary intervention to evaluate cognitive function: 1. CERAD Neuropsychological Assessment Battery 2. Domain Specific Tests (GDS, Babcock story Recall, Trail Making Test)
Time frame: 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.
Time frame: 1 year
Insulin sensitivity
Glucose, insulin and Hba1C will be measured on plasma pre and post dietary intervention
Time frame: 1 year
Liver Function Status
ASAT, ALAT, GGT and alkaline phosphatase parameters will be measured on plasma samples pre and post dietary intervention.
Time frame: 1 year
Hormonal Status
Leptin and adiponectin hormones will be measured on plasma samples pre and post dietary intervention
Time frame: 1 year
Nutritional Status
The Nutritional status will be evaluated on plasma measuring vitamin B12 and folate concentrations.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Physical Functioning
The following standardized questionnaires will be administered to volunteers pre and post dietary intervention to evaluate physical function: 1. SPPB 2. Hand grip test 3. Gait Speed Test 4. ADL, IADL 5. PASE
Time frame: 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: 1. Expression and responsiveness of Toll-like receptors, measured as production of downstream cytokines (IFN-a, IFN-b, IFN-y, IL12p40, IL12p70, SOCS3) 2. Expression of co-stimulatory molecules (CD1, MHC Class II, CD40, CD80, CD86, CD152, CD154, DC1/DC2)
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 1 year
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.
Time frame: 4 months
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 frame: Time 0
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
Time frame: 1 year
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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University of Bologna