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| Name | Class |
|---|---|
| European Commission | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Intervention | Experimental | 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. |
|
| Control Group | No Intervention | This group will follow the habitual diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Dietary Supplement | nutrient-rich diet and 10micrograms per day of Vitamin D (cholecalciferol) supplement from MCOHealth |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Status | The following standardized questionnaires will be administered to volunteers pre and post dietary intervention to evaluate cognitive function:
| 1 year |
| Cardiovascular Health Status |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Genetic profiling |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Franceschi, MD | University of Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auvergne Research Center on Human Nutrition | Clermont-Ferrand | 63009 | France | |||
| University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33515034 | Derived | Grootswagers P, Mensink M, Berendsen AAM, Deen CPJ, Kema IP, Bakker SJL, Santoro A, Franceschi C, Meunier N, Malpuech-Brugere C, Bialecka-Debek A, Rolf K, Fairweather-Tait S, Jennings A, Feskens EJM, de Groot LCPGM. Vitamin B-6 intake is related to physical performance in European older adults: results of the New Dietary Strategies Addressing the Specific Needs of the Elderly Population for Healthy Aging in Europe (NU-AGE) study. Am J Clin Nutr. 2021 Apr 6;113(4):781-789. doi: 10.1093/ajcn/nqaa368. | |
| 31559434 |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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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 |
| Insulin sensitivity | Glucose, insulin and Hba1C will be measured on plasma pre and post dietary intervention | 1 year |
| Liver Function Status | ASAT, ALAT, GGT and alkaline phosphatase parameters will be measured on plasma samples pre and post dietary intervention. | 1 year |
| Hormonal Status | Leptin and adiponectin hormones will be measured on plasma samples pre and post dietary intervention | 1 year |
| Nutritional Status | The Nutritional status will be evaluated on plasma measuring vitamin B12 and folate concentrations. | 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. | 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. | 1 year |
| Physical Functioning | The following standardized questionnaires will be administered to volunteers pre and post dietary intervention to evaluate physical function:
| 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 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. | 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. | 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". | 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". | 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". | 1 year |
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 |
| 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 |
| Bologna |
| Bologna |
| 40126 |
| Italy |
| University of Wageningen-Division of Human Nutrition | Wageningen | 6703 HD | Netherlands |
| Warsaw University of Life Science SGGW-WULS-Department of Human Nutrition | Warsaw | 02-776 | Poland |
| Department of Nurition-University of East Anglia | Norwich | NR4 7TJ | United Kingdom |
| Derived |
| Jennings A, Tang J, Gillings R, Perfecto A, Dutton J, Speakman J, Fraser WD, Nicoletti C, Berendsen AAM, de Groot LCPGM, Pietruszka B, Jeruszka-Bielak M, Caumon E, Caille A, Ostan R, Franceschi C, Santoro A, Fairweather-Tait SJ. Changing from a Western to a Mediterranean-style diet does not affect iron or selenium status: results of the New Dietary Strategies Addressing the Specific Needs of the Elderly Population for Healthy Aging in Europe (NU-AGE) 1-year randomized clinical trial in elderly Europeans. Am J Clin Nutr. 2020 Jan 1;111(1):98-109. doi: 10.1093/ajcn/nqz243. |
| 30890946 | Derived | Giampieri E, Ostan R, Guidarelli G, Salvioli S, Berendsen AAM, Brzozowska A, Pietruszka B, Jennings A, Meunier N, Caumon E, Fairweather-Tait S, Sicinska E, Feskens EJM, de Groot LCPGM, Franceschi C, Santoro A. A Novel Approach to Improve the Estimation of a Diet Adherence Considering Seasonality and Short Term Variability - The NU-AGE Mediterranean Diet Experience. Front Physiol. 2019 Mar 5;10:149. doi: 10.3389/fphys.2019.00149. eCollection 2019. |
| 30733683 | Derived | Pujos-Guillot E, Petera M, Jacquemin J, Centeno D, Lyan B, Montoliu I, Madej D, Pietruszka B, Fabbri C, Santoro A, Brzozowska A, Franceschi C, Comte B. Identification of Pre-frailty Sub-Phenotypes in Elderly Using Metabolomics. Front Physiol. 2019 Jan 24;9:1903. doi: 10.3389/fphys.2018.01903. eCollection 2018. |
| 30636547 | Derived | Jennings A, Berendsen AM, de Groot LCPGM, Feskens EJM, Brzozowska A, Sicinska E, Pietruszka B, Meunier N, Caumon E, Malpuech-Brugere C, Santoro A, Ostan R, Franceschi C, Gillings R, O' Neill CM, Fairweather-Tait SJ, Minihane AM, Cassidy A. Mediterranean-Style Diet Improves Systolic Blood Pressure and Arterial Stiffness in Older Adults. Hypertension. 2019 Mar;73(3):578-586. doi: 10.1161/HYPERTENSIONAHA.118.12259. |
| 30327612 | Derived | Ostan R, Guidarelli G, Giampieri E, Lanzarini C, Berendsen AAM, Januszko O, Jennings A, Lyon N, Caumon E, Gillings R, Sicinska E, Meunier N, Feskens EJM, Pietruszka B, de Groot LCPGM, Fairweather-Tait S, Capri M, Franceschi C, Santoro A. Cross-Sectional Analysis of the Correlation Between Daily Nutrient Intake Assessed by 7-Day Food Records and Biomarkers of Dietary Intake Among Participants of the NU-AGE Study. Front Physiol. 2018 Oct 1;9:1359. doi: 10.3389/fphys.2018.01359. eCollection 2018. |
| 30093866 | Derived | Maijo M, Ivory K, Clements SJ, Dainty JR, Jennings A, Gillings R, Fairweather-Tait S, Gulisano M, Santoro A, Franceschi C, Carding SR, Nicoletti C. One-Year Consumption of a Mediterranean-Like Dietary Pattern With Vitamin D3 Supplements Induced Small Scale but Extensive Changes of Immune Cell Phenotype, Co-receptor Expression and Innate Immune Responses in Healthy Elderly Subjects: Results From the United Kingdom Arm of the NU-AGE Trial. Front Physiol. 2018 Jul 26;9:997. doi: 10.3389/fphys.2018.00997. eCollection 2018. |
| 30007343 | Derived | Jennings A, Cashman KD, Gillings R, Cassidy A, Tang J, Fraser W, Dowling KG, Hull GLJ, Berendsen AAM, de Groot LCPGM, Pietruszka B, Wierzbicka E, Ostan R, Bazzocchi A, Battista G, Caumon E, Meunier N, Malpuech-Brugere C, Franceschi C, Santoro A, Fairweather-Tait SJ. A Mediterranean-like dietary pattern with vitamin D3 (10 microg/d) supplements reduced the rate of bone loss in older Europeans with osteoporosis at baseline: results of a 1-y randomized controlled trial. Am J Clin Nutr. 2018 Sep 1;108(3):633-640. doi: 10.1093/ajcn/nqy122. |
| 29670545 | Derived | Marseglia A, Xu W, Fratiglioni L, Fabbri C, Berendsen AAM, Bialecka-Debek A, Jennings A, Gillings R, Meunier N, Caumon E, Fairweather-Tait S, Pietruszka B, De Groot LCPGM, Santoro A, Franceschi C. Effect of the NU-AGE Diet on Cognitive Functioning in Older Adults: A Randomized Controlled Trial. Front Physiol. 2018 Apr 4;9:349. doi: 10.3389/fphys.2018.00349. eCollection 2018. |
| 28381473 | Derived | Fairweather-Tait SJ, Jennings A, Harvey LJ, Berry R, Walton J, Dainty JR. Modeling tool for calculating dietary iron bioavailability in iron-sufficient adults. Am J Clin Nutr. 2017 Jun;105(6):1408-1414. doi: 10.3945/ajcn.116.147389. Epub 2017 Apr 5. |
| 27225436 | Derived | Hooper L, Bunn DK, Abdelhamid A, Gillings R, Jennings A, Maas K, Millar S, Twomlow E, Hunter PR, Shepstone L, Potter JF, Fairweather-Tait SJ. Water-loss (intracellular) dehydration assessed using urinary tests: how well do they work? Diagnostic accuracy in older people. Am J Clin Nutr. 2016 Jul;104(1):121-31. doi: 10.3945/ajcn.115.119925. Epub 2016 May 25. |
| 26490100 | Derived | Hooper L, Abdelhamid A, Ali A, Bunn DK, Jennings A, John WG, Kerry S, Lindner G, Pfortmueller CA, Sjostrand F, Walsh NP, Fairweather-Tait SJ, Potter JF, Hunter PR, Shepstone L. Diagnostic accuracy of calculated serum osmolarity to predict dehydration in older people: adding value to pathology laboratory reports. BMJ Open. 2015 Oct 21;5(10):e008846. doi: 10.1136/bmjopen-2015-008846. |
| 24657127 | Derived | Berendsen A, Santoro A, Pini E, Cevenini E, Ostan R, Pietruszka B, Rolf K, Cano N, Caille A, Lyon-Belgy N, Fairweather-Tait S, Feskens E, Franceschi C, de Groot CP. Reprint of: A parallel randomized trial on the effect of a healthful diet on inflammageing and its consequences in European elderly people: design of the NU-AGE dietary intervention study. Mech Ageing Dev. 2014 Mar-Apr;136-137:14-21. doi: 10.1016/j.mad.2014.03.001. Epub 2014 Mar 20. |
| 24333321 | Derived | Hooper L, Bunn D, Jimoh FO, Fairweather-Tait SJ. Water-loss dehydration and aging. Mech Ageing Dev. 2014 Mar-Apr;136-137:50-8. doi: 10.1016/j.mad.2013.11.009. Epub 2013 Dec 9. |
| 24275120 | Derived | Fairweather-Tait SJ, Wawer AA, Gillings R, Jennings A, Myint PK. Iron status in the elderly. Mech Ageing Dev. 2014 Mar-Apr;136-137:22-8. doi: 10.1016/j.mad.2013.11.005. Epub 2013 Nov 22. |