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

NCT04786925 | Completed

• 1 other identifier: NUTRIPRECISION
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obesity; Health status; Insulin resistance; Hypertension; Lipid profile; Gastrointestinal health; Cognitive capacity; Life quality; Healthy ageing; Lifestyle intervention; Precision nutrition; Mediterranean diet; Eating behaviour; Physical activity; Oxidative stress; Inflammation; Functional ability; Nutrition education

Outcome Measures

Primary Outcomes (1)

• Change From Baseline General Health Status at 3 Months

  General health score encompassed twelve parameters, on a scale of 0 to 21, with higher scores indicating a worse overall health: * BMI * Waist Circumference * Glycosylated hemoglobin (HbA1C) * Total cholesterol * HDL-cholesterol * LDL-cholesterol * Triglycerides * Uric acid * Systolic Blood Pressure \| Diastolic Blood Pressure * Gastrointestinal Health (GSRT) * Cognitive Function * Extra negative point if reducing medication

  0 months and 3 months

Secondary Outcomes (55)

• Change From Baseline Weight at 3 Months

  0 months and 3 months

• Baseline height

  0 months

• Change From Baseline Body Mass Index at 3 Months

  0 months and 3 months

• Change From Baseline Fat Mass at 3 Months

  0 months and 3 months

• Change From Baseline Lean Mass at 3 Months

  0 months and 3 months

Study Arms (2)

Control diet

PLACEBO COMPARATOR

A conventional diet based on the current Spanish Mediterranean dietary guidelines: Spanish Society of Community Nutrition (SENC).

Other: Control diet

Nutriprecision diet

EXPERIMENTAL

A Mediterranean, balanced diet based on the inclusion of precision foods designed and developed within the framework of Nutriprecision project. A mobile application to empower and support the management of the dietary prescription. A digital tool for cognitive stimulation.

Other: Nutriprecision diet

Interventions

Control diet OTHER

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.

Control diet

Nutriprecision diet OTHER

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.

Nutriprecision diet

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 50-80 years
• BMI \>27 kg/m2
• One or more of the following risk factors:
• Glucose ≥100 to ≤125 mg/dL or type 2 diabetes (independently of antidiabetic medication)
• Hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg or under antihypertensive medication)
• LDL-cholesterol ≥160 mg/dL independently of lipid-lowering therapy
• HDL-cholesterol ≤40 mg/dL (men)/≤50 mg/dL (women), independently of lipid-lowering therapy
• Triglycerides ≥160 mg/dL independently of lipid-lowering therapy
• Waist Circumference ˃95 cm (men)/\>82 cm (women), independently of lipid-lowering therapy
• Sedentary behavior (AHA)\*

You may not qualify if:

• Relevant functional or structural digestive abnormalities (malformations, angiodysplasia, active peptic ulcers, chronic inflammatory diseases, or malabsorption)
• Endocrine disorders (hyperthyroidism or uncontrolled hypothyroidism)
• Undergone surgical interventions with permanent sequelae (gastroduodenostomy)
• Pharmacological treatments with immunosuppressants, cytotoxic agents, systemic corticosteroids, or other drugs that could potentially cause hepatic steatosis or alteration of liver tests
• Active cancer in the last five years or under therapy
• Weight loss ≥3 kg in the last three months
• Instable drug therapy in the last three months
• Severe psychiatric disorders
• No autonomy
• Inability to follow the diet (food allergies, intolerances)
• Difficulties to follow scheduled visits
• AHA Recommendations for Physical Activity in Adults: at least 150 minutes per week of moderate-intensity aerobic activity or 75 minutes per week of vigorous aerobic activity, or a combination of both, preferably spread throughout the week.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Centre for Nutrition Research, University of Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (3)

• de Toro-Martin J, Arsenault BJ, Despres JP, Vohl MC. Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome. Nutrients. 2017 Aug 22;9(8):913. doi: 10.3390/nu9080913.

  PMID: 28829397 BACKGROUND

• Gonzalez-Muniesa P, Martinez JA. Precision Nutrition and Metabolic Syndrome Management. Nutrients. 2019 Oct 9;11(10):2411. doi: 10.3390/nu11102411.

  PMID: 31601025 BACKGROUND

• Brooke, JB (1996). SUS - a quick and dirty usability scale. In: Usability Evaluation in Industry, Jordan, P, Thomas, B, Weerdmeester, B, and McLelland, I(eds), Taylor and Francis: London

  BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Insulin Resistance; Hypertension; Feeding Behavior; Motor Activity; Inflammation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior, Animal; Behavior; Pathologic Processes

Study Officials

• Itziar Abete Goñi, PhD

  Centre for Nutrition Research - University of Navarra

  PRINCIPAL INVESTIGATOR

• Santiago Navas Carretero, PhD

  Centre for Nutrition Research - University of Navarra

  PRINCIPAL INVESTIGATOR

• M Ángeles Zulet Alzórriz, Professor

  Centre for Nutrition Research - University of Navarra

  STUDY DIRECTOR

• Carlos Javier González Navarro, PhD

  Centre for Nutrition Research - University of Navarra

  STUDY DIRECTOR

• J. Alfredo Martínez Hernández, Professor

  Centre for Nutrition Research - University of Navarra

  STUDY DIRECTOR

• Viviana Loria Kohen, PhD

  IMDEA Food

  PRINCIPAL INVESTIGATOR

• Ana Ramirez Molina, PhD

  IMDEA Food

  STUDY CHAIR

• Guillermo Reglero Rada, Professor

  IMDEA Food

  STUDY CHAIR

• Elena Aguilar Aguilar, PhD

  IMDEA Food

  STUDY CHAIR

• Helena Marcos Pasero

  IMDEA Food

  STUDY CHAIR

• Susana Molina

  IMDEA Food

  STUDY CHAIR

• Carmen Crespo

  IMDEA Food

  STUDY CHAIR

• Cristina Galarregui Miquelarena

  Centre for Nutrition Research - University of Navarra

  STUDY CHAIR

• Blanca Martínez de Morentín, MD

  Centre for Nutrition Research - University of Navarra

  STUDY CHAIR

• Salomé Pérez Díez

  Centre for Nutrition Research - University of Navarra

  STUDY CHAIR

• María Hernández Ruiz de Eguilaz

  Centre for Nutrition Research - University of Navarra

  STUDY CHAIR

• Veronica Ciaurriz Fernández

  Centre for Nutrition Research - University of Navarra

  STUDY CHAIR

• María Zabala Navó

  Centre for Nutrition Research - University of Navarra

  STUDY CHAIR

• Begoña de Cuevillas García

  Centre for Nutrition Research - University of Navarra

  STUDY CHAIR

• José Manuel Iniesta Chamorro

  Universidad Politécnica de Madrid (UPM)

  STUDY CHAIR

• Paloma Chausa Fernández

  Universidad Politécnica de Madrid (UPM)

  STUDY CHAIR

• José Tapia Galisteo

  Universidad Politécnica de Madrid (UPM)

  STUDY CHAIR

• Elena Hernando Pérez

  Universidad Politécnica de Madrid (UPM)

  STUDY CHAIR

• Enrique J. Gómez Aguilera

  Universidad Politécnica de Madrid (UPM)

  STUDY CHAIR

• Alexis Álvarez Rollán

  Grupo I.C.A. Informática y Comunicaciones Avanzadas, S.L.

  STUDY CHAIR

• 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

  STUDY CHAIR

• 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

  STUDY CHAIR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The participants are randomly assigned to Control or NUTRIPRECISION strategy.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: October 16, 2018
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)