Clinical trial NCT04786925: Precision Nutrition Strategies for Improving the Quality of Life of Pre-senior and Senior Populations
Official title: Strategies for Improving the Quality of Life of Pre-senior and Senior Populations Based on Precision Nutrition (Proyecto Nutriprecisión)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 126
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants are randomly assigned to Control or NUTRIPRECISION strategy.
Primary purpose: TREATMENT

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.

Detailed description: This study is designed as a 12-week, randomized parallel intervention trial, with two arms: 1) Control group, who follows a control diet based on the current dietary guidelines of the Spanish Society of Community Nutrition (SENC) using the Healthy Eating Plate method (Harvard), and 2) Nutriprecision Group, which were instructed to follow the Nutriprecision diet based on the inclusion of digital tools and functional foods, whose postprandial effects were previously evaluated by randomized, cross-over, double-blind studies in senior subjects in the Centre for Nutrition Research (UNAV) and IMDEA-ALIMENTACIÓN. The incremental area under the curve (iAUC) for glucose and insulin was calculated for all designed foods and was compared with their reference products. Additionally, lipid profile and satiety were measured at fasting and at 15, 30, 45, 60, 90, and 120 min after starting the food intake. In all these studies, the reference and test foods were administered once in random order, with a wash-out period between 7 days and 14 days among assays.

This multi-centric study was carried out in the Nutrition Intervention Unit of the Centre for Nutrition Research in the University of Navarra and the Nutritional and Clinical Trials Unit in IMDEA-ALIMENTACIÓN by qualified professionals (nurse, doctor-dietician, dieticians, pharmacists).

A total of five visits had been established along with the 12-weeks trial: 1) study information and screening; 2) day 0: start of the intervention; 3) day 28: group session (control group)/follow-up visit (Nutriprecision group); 4) day 56: group session (control group)/follow-up visit (Nutriprecision group) and 5) day 84: end of the intervention.

At the start and finish days of the study, participants visited the Nutrition Intervention Unit or the Clinical Trials Unit in a fasting state. Participants were instructed to collect the first-morning urine sample. Additionally, volunteers from the University of Navarra self-collected fecal samples at baseline using OMNIgene.GUT kits from DNA Genotek. Volunteers were also informed of a digital-based procedure for cognitive assessment and other digital tools available depending on the assigned intervention (experimental VS control).

Blood samples were drawn by venipuncture after a 12 h overnight fast in a clinical setting. After 10 minutes of rest and having answered the Mini Nutritional Assessment (MNA) and the Mini-Mental State Examination (MMSE) questionnaires, blood pressure was measured. Later, anthropometric measurements and body composition analysis were performed. Global cognitive performance was also assessed by the Guttmann NeuroPersonalTrainer platform. The duration of these visits was approximately 1 hour.

On the 28th and 56th study days, participants assigned to the control group attended online group sessions and received intensive education and advice to increase the adherence to the dietary strategy. Sessions consisted of informative talks about the prescribed dietary pattern, food label use, seasonal shopping lists, meal plans and recipes, physical activity and exercise recommendations, sleep habits, etc. Contrary, participants allocated to the Nutriprecision group attended in person visits with the dieticians, to evaluate the adherence to the assigned nutritional treatment. Additionally, anthropometric, body composition, and blood pressure measurements were assessed. Participants were also asked to fill different questionnaires about health status (SF-36 Health Survey), gastrointestinal symptoms (gastrointestinal symptoms rating scale, GSRT), dietary assessment (7-day recall), Mediterranean diet adherence (14-Item Mediterranean Diet Assessment Tool), physical activity (International Physical Activity Questionnaire, IPAQ) and drug therapy modifications. Moreover, the Nutriprecision group were asked to collect a sensory perception questionnaire and a food consumption record of the precision foods administered.

Eligibility criteria: Inclusion Criteria:

* 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)\*

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline General Health Status at 3 Months
timeFrame: 0 months and 3 months
Secondary outcomes:
measure: Change From Baseline Weight at 3 Months
timeFrame: 0 months and 3 months
measure: Baseline height
timeFrame: 0 months
measure: Change From Baseline Body Mass Index at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Fat Mass at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Lean Mass at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Waist Circumference at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Hip Circumference at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Systolic Blood Pressure at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Diastolic Blood Pressure at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Serum Triglycerides at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Serum Total Cholesterol at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Serum LDL-Cholesterol at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Serum HDL-Cholesterol at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Serum Uric Acid at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Serum Glucose at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Serum Insulin at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Serum Glycosylated hemoglobin (HbA1C) at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Serum Aspartate Aminotransferase at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Serum Alanine Aminotransferase at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Serum Gamma-glutamyltransferase at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Physical Activity Level at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Dietary Intake at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Mediterranean Diet Adherence at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Health Status at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Gastrointestinal Symptoms at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Sensory Perception of Precision Foods at 3 Months
timeFrame: 1 month and 3 months
measure: Food Consumption of the Precision Foods
timeFrame: 1 month, 2 months and 3 months
measure: Change From Baseline Risk of Malnutrition at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Cognitive Impairment at 3 Months
timeFrame: 0 months and 3 months
measure: Change From Baseline Cognitive Function at 3 Months
timeFrame: 0 months and 3 months
measure: Baseline Gut Microbiota Composition
timeFrame: 0 months
measure: Usability of the digital tools
timeFrame: 3 months
measure: Baseline subjective hunger
timeFrame: Baseline
measure: Postprandial subjective hunger
timeFrame: Up to 120 minutes
measure: Baseline subjective fullness
timeFrame: Baseline
measure: Postprandial subjective fullness
timeFrame: Up to 120 minutes
measure: Baseline subjective satiety
timeFrame: Baseline
measure: Postprandial subjective satiety
timeFrame: Up to 120 minutes
measure: Baseline subjective desire to eat
timeFrame: Baseline
measure: Postprandial subjective desire to eat
timeFrame: Up to 120 minutes
measure: Baseline subjective thirst
timeFrame: Baseline
measure: Postprandial subjective thirst
timeFrame: Up to 120 minutes
measure: Baseline blood glucose concentration
timeFrame: Baseline
measure: Baseline blood insulin concentration
timeFrame: Baseline
measure: Incremental area under the curve (iAUC) for glucose
timeFrame: 0,15,30,45,60,90,120
measure: Incremental area under the curve (iAUC) for insulin
timeFrame: 0,15,30,45,60,90,120
measure: Baseline blood high density lipoprotein cholesterol (HDL) concentration
timeFrame: Baseline
measure: Baseline blood low density lipoprotein cholesterol (LDL) concentration
timeFrame: Baseline
measure: Baseline blood triglyceride concentration
timeFrame: Baseline
measure: Postprandial blood glucose concentration
timeFrame: Up to 120 minutes
measure: Postprandial blood insulin concentration
timeFrame: Up to 120 minutes
measure: Postprandial blood total cholesterol concentration
timeFrame: Up to 120 minutes
measure: Postprandial blood high density lipoprotein cholesterol (HDL) concentration
timeFrame: Up to 120 minutes
measure: Postprandial blood low density lipoprotein cholesterol (LDL) concentration
timeFrame: Up to 120 minutes
measure: Postprandial blood triglyceride concentration
timeFrame: Up to 120 minutes
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Centre for Nutrition Research, University of Navarra
state: Navarra
Study officials:
affiliation: Centre for Nutrition Research - University of Navarra
name: Itziar Abete Goñi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Nutrition Research - University of Navarra
name: Santiago Navas Carretero, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Nutrition Research - University of Navarra
name: M Ángeles Zulet Alzórriz, Professor
role: STUDY_DIRECTOR
affiliation: Centre for Nutrition Research - University of Navarra
name: Carlos Javier González Navarro, PhD
role: STUDY_DIRECTOR
affiliation: Centre for Nutrition Research - University of Navarra
name: J. Alfredo Martínez Hernández, Professor
role: STUDY_DIRECTOR
affiliation: IMDEA Food
name: Viviana Loria Kohen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IMDEA Food
name: Ana Ramirez Molina, PhD
role: STUDY_CHAIR
affiliation: IMDEA Food
name: Guillermo Reglero Rada, Professor
role: STUDY_CHAIR
affiliation: IMDEA Food
name: Elena Aguilar Aguilar, PhD
role: STUDY_CHAIR
affiliation: IMDEA Food
name: Helena Marcos Pasero
role: STUDY_CHAIR
affiliation: IMDEA Food
name: Susana Molina
role: STUDY_CHAIR
affiliation: IMDEA Food
name: Carmen Crespo
role: STUDY_CHAIR
affiliation: Centre for Nutrition Research - University of Navarra
name: Cristina Galarregui Miquelarena
role: STUDY_CHAIR
affiliation: Centre for Nutrition Research - University of Navarra
name: Blanca Martínez de Morentín, MD
role: STUDY_CHAIR
affiliation: Centre for Nutrition Research - University of Navarra
name: Salomé Pérez Díez
role: STUDY_CHAIR
affiliation: Centre for Nutrition Research - University of Navarra
name: María Hernández Ruiz de Eguilaz
role: STUDY_CHAIR
affiliation: Centre for Nutrition Research - University of Navarra
name: Veronica Ciaurriz Fernández
role: STUDY_CHAIR
affiliation: Centre for Nutrition Research - University of Navarra
name: María Zabala Navó
role: STUDY_CHAIR
affiliation: Centre for Nutrition Research - University of Navarra
name: Begoña de Cuevillas García
role: STUDY_CHAIR
affiliation: Universidad Politécnica de Madrid (UPM)
name: José Manuel Iniesta Chamorro
role: STUDY_CHAIR
affiliation: Universidad Politécnica de Madrid (UPM)
name: Paloma Chausa Fernández
role: STUDY_CHAIR
affiliation: Universidad Politécnica de Madrid (UPM)
name: José Tapia Galisteo
role: STUDY_CHAIR
affiliation: Universidad Politécnica de Madrid (UPM)
name: Elena Hernando Pérez
role: STUDY_CHAIR
affiliation: Universidad Politécnica de Madrid (UPM)
name: Enrique J. Gómez Aguilera
role: STUDY_CHAIR
affiliation: Grupo I.C.A. Informática y Comunicaciones Avanzadas, S.L.
name: Alexis Álvarez Rollán
role: STUDY_CHAIR
affiliation: 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
name: Alejandro García Rudolph
role: STUDY_CHAIR
affiliation: 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
name: Alberto García Molina
role: STUDY_CHAIR
affiliation: 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
name: Josep Maria Tormos Muñoz
role: STUDY_CHAIR
References:
citation: 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.
citation: Gonzalez-Muniesa P, Martinez JA. Precision Nutrition and Metabolic Syndrome Management. Nutrients. 2019 Oct 9;11(10):2411. doi: 10.3390/nu11102411.
citation: 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