Precision Nutrition Strategies for Improving the Quality of Life of Pre-senior and Senior Populations
Condition: Overweight or Obesity
MeSH terms: Overweight
Study type: Interventional

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.
    

Intervention name(s): Control diet; Nutriprecision diet
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants are randomly assigned to Control or NUTRIPRECISION strategy.
Masking: None (Open Label)
Primary purpose: Treatment
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