European Project on Nutrition in Elderly People (NU-AGE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01754012|
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : February 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Aging||Dietary Supplement: Dietary Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||New Dietary Strategies Addressing the Specific Needs of Elderly Population for an Healthy Aging in Europe|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
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
No Intervention: Control Group
This group will follow the habitual diet.
- Inflammatory Response [ Time Frame: 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.
- Cognitive Status [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]Glucose, insulin and Hba1C will be measured on plasma pre and post dietary intervention
- Liver Function Status [ Time Frame: 1 year ]ASAT, ALAT, GGT and alkaline phosphatase parameters will be measured on plasma samples pre and post dietary intervention.
- Hormonal Status [ Time Frame: 1 year ]Leptin and adiponectin hormones will be measured on plasma samples pre and post dietary intervention
- Nutritional Status [ Time Frame: 1 year ]The Nutritional status will be evaluated on plasma measuring vitamin B12 and folate concentrations.
- Digestive Health Status [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]
The following standardized questionnaires will be administered to volunteers pre and post dietary intervention to evaluate physical function:
- Hand grip test
- Gait Speed Test
- ADL, IADL
- Changes on Cellular and Molecular mechanisms after diet: Immunological Status [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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".
- Habitual Diet [ Time Frame: 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 Frame: 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 [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754012
|Auvergne Research Center on Human Nutrition|
|Clermont-Ferrand, France, 63009|
|University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine|
|Bologna, Italy, 40126|
|University of Wageningen-Division of Human Nutrition|
|Wageningen, Netherlands, 6703 HD|
|Warsaw University of Life Science SGGW-WULS-Department of Human Nutrition|
|Warsaw, Poland, 02-776|
|Department of Nurition-University of East Anglia|
|Norwich, United Kingdom, NR4 7TJ|
|Principal Investigator:||Claudio Franceschi, MD||University of Bologna|