Strategies for Improving the Quality of Life of Pre-senior and Senior Populations Based on Precision Nutrition (Proyecto Nutriprecisión)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change From Baseline General Health Status at 3 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)*
排除标准
- •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.
研究组 & 干预措施
Control diet
A conventional diet based on the current Spanish Mediterranean dietary guidelines: Spanish Society of Community Nutrition (SENC).
干预措施: Control diet (Other)
Nutriprecision diet
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.
干预措施: Nutriprecision diet (Other)
结局指标
主要结局
Change From Baseline General Health Status at 3 Months
时间窗: 0 months and 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
次要结局
- Change From Baseline Body Mass Index at 3 Months(0 months and 3 months)
- Change From Baseline Weight at 3 Months(0 months and 3 months)
- Baseline height(0 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)
- Change From Baseline Serum Uric Acid at 3 Months(0 months and 3 months)
- Change From Baseline Serum Insulin at 3 Months(0 months and 3 months)
- Change From Baseline Serum Aspartate Aminotransferase at 3 Months(0 months and 3 months)
- Change From Baseline Physical Activity Level at 3 Months(0 months and 3 months)
- Change From Baseline Sensory Perception of Precision Foods at 3 Months(1 month and 3 months)
- Food Consumption of the Precision Foods(1 month, 2 months and 3 months)
- Change From Baseline Hip Circumference at 3 Months(0 months and 3 months)
- Change From Baseline Systolic Blood Pressure at 3 Months(0 months and 3 months)
- Change From Baseline Diastolic Blood Pressure at 3 Months(0 months and 3 months)
- Change From Baseline Serum LDL-Cholesterol at 3 Months(0 months and 3 months)
- Change From Baseline Mediterranean Diet Adherence at 3 Months(0 months and 3 months)
- Change From Baseline Waist Circumference at 3 Months(0 months and 3 months)
- Change From Baseline Serum Glucose at 3 Months(0 months and 3 months)
- Change From Baseline Serum Glycosylated hemoglobin (HbA1C) at 3 Months(0 months and 3 months)
- Change From Baseline Serum Gamma-glutamyltransferase at 3 Months(0 months and 3 months)
- Baseline subjective satiety(Baseline)
- Baseline subjective desire to eat(Baseline)
- Postprandial subjective desire to eat(Up to 120 minutes)
- Postprandial subjective thirst(Up to 120 minutes)
- Incremental area under the curve (iAUC) for insulin(0,15,30,45,60,90,120)
- Baseline blood low density lipoprotein cholesterol (LDL) concentration(Baseline)
- Postprandial blood total cholesterol concentration(Up to 120 minutes)
- Postprandial blood high density lipoprotein cholesterol (HDL) concentration(Up to 120 minutes)
- Change From Baseline Serum HDL-Cholesterol at 3 Months(0 months and 3 months)
- Change From Baseline Health Status at 3 Months(0 months and 3 months)
- Change From Baseline Cognitive Function at 3 Months(0 months and 3 months)
- Postprandial subjective hunger(Up to 120 minutes)
- Postprandial subjective fullness(Up to 120 minutes)
- Baseline subjective thirst(Baseline)
- Baseline blood high density lipoprotein cholesterol (HDL) concentration(Baseline)
- Postprandial blood triglyceride concentration(Up to 120 minutes)
- Change From Baseline Serum Triglycerides at 3 Months(0 months and 3 months)
- Change From Baseline Serum Total Cholesterol at 3 Months(0 months and 3 months)
- Change From Baseline Serum Alanine Aminotransferase at 3 Months(0 months and 3 months)
- Change From Baseline Dietary Intake at 3 Months(0 months and 3 months)
- Change From Baseline Gastrointestinal Symptoms at 3 Months(0 months and 3 months)
- Change From Baseline Risk of Malnutrition at 3 Months(0 months and 3 months)
- Change From Baseline Cognitive Impairment at 3 Months(0 months and 3 months)
- Baseline subjective hunger(Baseline)
- Baseline subjective fullness(Baseline)
- Incremental area under the curve (iAUC) for glucose(0,15,30,45,60,90,120)
- Postprandial subjective satiety(Up to 120 minutes)
- Baseline blood glucose concentration(Baseline)
- Baseline blood insulin concentration(Baseline)
- Baseline blood triglyceride concentration(Baseline)
- Postprandial blood glucose concentration(Up to 120 minutes)
- Baseline Gut Microbiota Composition(0 months)
- Usability of the digital tools(3 months)
- Postprandial blood insulin concentration(Up to 120 minutes)
- Postprandial blood low density lipoprotein cholesterol (LDL) concentration(Up to 120 minutes)
研究者
Itziar Abete
Principal Investigator
Clinica Universidad de Navarra, Universidad de Navarra