Precision Nutrition Strategies for Improving the Quality of Life of Pre-senior and Senior Populations

NCT04786925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2021-03-08

No results posted yet for this study

Summary

The number and proportion of people aged 60 years old and over is increasing worldwide. Ageing is characterized by a progressive loss of physiological integrity, leading to impaired function and increased vulnerability to death. This deterioration is the primary risk factor for major chronic diseases including diabetes, cardiovascular disease, and neurodegenerative disorders.

The incidence of chronic conditions frequently rises sharply with age, after long exposure to unhealthful lifestyles involving the consumption of unhealthy diets and physical inactivity. Consequently, integrated dietary strategies and actions are required to promote healthy ageing and target major causes of morbidity and mortality in senior populations.

The promising field of precision nutrition is rising as a therapeutic approach that aims to design tailored dietary interventions to prevent and manage chronic diseases. Indeed, precision nutrition approaches contemplate the interindividual heterogeneity caused by genetic/epigenetic dissimilarities, individual facets such as age and gender, the lifestyle and environmental exposome diversity, microbiome variations, and singular behavioral/psychological features.

On the other hand, the inclusion of potentially bioactive compounds and functional foods as promoters of healthy aging within personalised dietary patterns could be an effective strategy to delay the aging process and age-related chronic diseases.

One of the main limitations of a dietary prescription is the lack of compliance, due to the complexity of the prescription itself and/or the lack of commitment of the individual. The inclusion of digital tools to empower and motivate individuals and to support them in the management of the dietary strategy could overcome this limitation.

With this background, the general objective of this investigation is to design precision nutritional strategies based on the inclusion of functional foods and digital tools for preventing age-related chronic diseases in pre-senior and senior populations. Additionally, this study proposes alternative tools for cognitive assessments increasing the accessibility to cognitive assessment tools for this population as well as an innovative digital tool for cognitive stimulation which is personalized, monitored, and evidence-based.

Conditions

  • Overweight or Obesity

Interventions

OTHER

Control diet

Control diet: A Mediterranean conventional diet based on the current dietary guidelines of the Spanish Society of Community Nutrition (SENC). Participants were strongly advised to use the Healthy Eating Plate (Harvard) to structure and prepare the main meals (lunch and dinner). In this way, at least ½ of the plate should be composed of vegetables, ¼ of lean protein, and ¼ of low glycemic index carbohydrates. The diet encourages participants to eat 5 times/day (breakfast, lunch, dinner, and two snacks). Overall, the control diet was based on high consumption of vegetables and fruits, whole grains, healthy fats (olive oil), and healthy proteins (legumes, fish, and lean meat). There was not energy restriction in the control diet.

OTHER

Nutriprecision diet

Nutriprecision diet: a Mediterranean balanced diet based on the inclusion of precision foods designed according to the particularities of the senior population. The selected precision foods were a) fruit compote, b) smoothie, c) extruded meat product, d) wholemeal bread, e) wholemeal biscuit and f) microwaveable deep-frozen vegetable products. The diet encourages participants to eat 5 times/day with a conventionally balanced distribution of macronutrients (50% of the total caloric value from carbohydrates, 20% from proteins, and 30% from lipids). There was not energy restriction, although the energy requirements of the participants were adjusted to a BMI of 25 kg/m2 to avoid an overestimate of calorie intake. A mobile application designed and developed to provide volunteers with information about follow-up visits, the assigned diet, recommendations, and messages to motivate them during the intervention. A digital tool for cognitive stimulation.

Sponsors & Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Principal Investigators

  • Itziar Abete Goñi, PhD · Centre for Nutrition Research - University of Navarra

  • Santiago Navas Carretero, PhD · Centre for Nutrition Research - University of Navarra

  • M Ángeles Zulet Alzórriz, Professor · Centre for Nutrition Research - University of Navarra

  • Carlos Javier González Navarro, PhD · Centre for Nutrition Research - University of Navarra

  • J. Alfredo Martínez Hernández, Professor · Centre for Nutrition Research - University of Navarra

  • Viviana Loria Kohen, PhD · IMDEA Food

  • Ana Ramirez Molina, PhD · IMDEA Food

  • Guillermo Reglero Rada, Professor · IMDEA Food

  • Elena Aguilar Aguilar, PhD · IMDEA Food

  • Helena Marcos Pasero · IMDEA Food

  • Susana Molina · IMDEA Food

  • Carmen Crespo · IMDEA Food

  • Cristina Galarregui Miquelarena · Centre for Nutrition Research - University of Navarra

  • Blanca Martínez de Morentín, MD · Centre for Nutrition Research - University of Navarra

  • Salomé Pérez Díez · Centre for Nutrition Research - University of Navarra

  • María Hernández Ruiz de Eguilaz · Centre for Nutrition Research - University of Navarra

  • Veronica Ciaurriz Fernández · Centre for Nutrition Research - University of Navarra

  • María Zabala Navó · Centre for Nutrition Research - University of Navarra

  • Begoña de Cuevillas García · Centre for Nutrition Research - University of Navarra

  • José Manuel Iniesta Chamorro · Universidad Politécnica de Madrid (UPM)

  • Paloma Chausa Fernández · Universidad Politécnica de Madrid (UPM)

  • José Tapia Galisteo · Universidad Politécnica de Madrid (UPM)

  • Elena Hernando Pérez · Universidad Politécnica de Madrid (UPM)

  • Enrique J. Gómez Aguilera · Universidad Politécnica de Madrid (UPM)

  • Alexis Álvarez Rollán · Grupo I.C.A. Informática y Comunicaciones Avanzadas, S.L.

  • Alejandro García Rudolph · Institut Guttmann, University Institute attached to the Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain; Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Spain; The Health Sciences Research Institute of the Germans

  • Alberto García Molina · Institut Guttmann, University Institute attached to the Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain; Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Spain; The Health Sciences Research Institute of the Germans

  • Josep Maria Tormos Muñoz · Institut Guttmann, University Institute attached to the Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain; Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Spain; The Health Sciences Research Institute of the Germans

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2020-12-23
Completion
2020-12-23

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04786925 on ClinicalTrials.gov