Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04786925
Status:
COMPLETED
Last Update Posted:
2021-03-08
First Post:
2021-03-03
Brief Title:
Precision Nutrition Strategies for Improving the Quality of Life of Pre-senior and Senior Populations
Sponsor:
Clinica Universidad de Navarra Universidad de Navarra
Organization:
Clinica Universidad de Navarra Universidad de Navarra
Study Overview
Official Title:
Strategies for Improving the Quality of Life of Pre-senior and Senior Populations Based on Precision Nutrition Proyecto Nutriprecisión
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 geneticepigenetic dissimilarities individual facets such as age and gender the lifestyle and environmental exposome diversity microbiome variations and singular behavioralpsychological 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 andor 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
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 geneticepigenetic dissimilarities individual facets such as age and gender the lifestyle and environmental exposome diversity microbiome variations and singular behavioralpsychological 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 andor 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 groupfollow-up visit Nutriprecision group 4 day 56 group session control groupfollow-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 OMNIgeneGUT 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
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 groupfollow-up visit Nutriprecision group 4 day 56 group session control groupfollow-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 OMNIgeneGUT 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None