Clinical trial NCT01754012: European Project on Nutrition in Elderly People
Official title: New Dietary Strategies Addressing the Specific Needs of Elderly Population for an Healthy Aging in Europe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Nutrition
Dietary intervention
Aging
Inflammation
Elderly
Europe
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2012-12-21
Enrollment: 1190
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Inflammatory Response
timeFrame: 1 year
Secondary outcomes:
measure: Cognitive Status
timeFrame: 1 year
measure: Cardiovascular Health Status
timeFrame: 1 year
measure: Insulin sensitivity
timeFrame: 1 year
measure: Liver Function Status
timeFrame: 1 year
measure: Hormonal Status
timeFrame: 1 year
measure: Nutritional Status
timeFrame: 1 year
measure: Digestive Health Status
timeFrame: 1 year
measure: Bone Health Status
timeFrame: 1 year
measure: Physical Functioning
timeFrame: 1 year
measure: Changes on Cellular and Molecular mechanisms after diet: Immunological Status
timeFrame: 1 year
measure: Changes on Cellular and Molecular mechanisms after diet: Epigenetic signature
timeFrame: 1 year
measure: Changes on Cellular and Molecular mechanisms after diet: biochemical modifications
timeFrame: 1 year
measure: Transcriptomics
timeFrame: 1 year
measure: Metabolomics
timeFrame: 1 year
measure: Metagenomics
timeFrame: 1 year
Other outcomes:
measure: Habitual Diet
timeFrame: 4 months
measure: Genetic profiling
timeFrame: Time 0
measure: General Health information
timeFrame: 1 year
Locations:
city: Clermont-Ferrand
country: France
facility: Auvergne Research Center on Human Nutrition
city: Bologna
country: Italy
facility: University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine
city: Wageningen
country: Netherlands
facility: University of Wageningen-Division of Human Nutrition
city: Warsaw
country: Poland
facility: Warsaw University of Life Science SGGW-WULS-Department of Human Nutrition
city: Norwich
country: United Kingdom
facility: Department of Nurition-University of East Anglia
Study officials:
affiliation: University of Bologna
name: Claudio Franceschi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.