Overweight or ObesityNCT04786925
Precision Nutrition Strategies for Improving the Quality of Life of Pre-senior and Senior Populations
A study testing Nutriprecision diet in people with Overweight or Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- Nutriprecision diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteSpain
- Study dates
- 16 Oct 2018to 23 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)*
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centre for Nutrition Research, University of Navarra
Pamplona, Navarre, 31008
About this study
Official title: Strategies for Improving the Quality of Life of Pre-senior and Senior Populations Based on Precision Nutrition (Proyecto Nutriprecisión)
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.
Read more
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.
Read the 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.
- Conditions
- Overweight or Obesity
- Being tested
- Control diet, Nutriprecision diet
- 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
- Medical subject headings
- Overweight, Obesity, Insulin Resistance, Hypertension, Feeding Behavior, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control dietOther
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 dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control diet | Placebo comparator | A conventional diet based on the current Spanish Mediterranean dietary guidelines: Spanish Society of Community Nutrition (SENC). Receives: 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. Receives: Other: Nutriprecision diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 months and 3 months
Secondary outcomes (55)
Change From Baseline Weight at 3 Months
Weight was measured by a digital scale
Measured: 0 months and 3 months
Baseline height
Height was recorded using a wall-mounted stadiometer (Seca 220, Vogel \& Halke, Germany).
Measured: 0 months
Change From Baseline Body Mass Index at 3 Months
Body mass index was calculated using the standard formula: weight (kg)/height (m)2
Measured: 0 months and 3 months
Change From Baseline Fat Mass at 3 Months
Fat mass was measured by Bioelectrical impedance analysis (BIA, SC-330, Tanita)
Measured: 0 months and 3 months
Change From Baseline Lean Mass at 3 Months
Lean mass was measured by Bioelectrical impedance analysis (BIA, SC-330, Tanita)
Measured: 0 months and 3 months
Change From Baseline Waist Circumference at 3 Months
Waist Circumference was measured by with a tape measure
Measured: 0 months and 3 months
Change From Baseline Hip Circumference at 3 Months
Hip Circumference was measured by with a tape measure
Measured: 0 months and 3 months
Change From Baseline Systolic Blood Pressure at 3 Months
Systolic Blood Pressure was measured using an automatic monitor device (Intelli Sense. M6, OMRON Healthcare, Hoofdorp, the Netherlands)
Measured: 0 months and 3 months
Change From Baseline Diastolic Blood Pressure at 3 Months
Diastolic Blood Pressure was measured using an automatic monitor device (Intelli Sense. M6, OMRON Healthcare, Hoofdorp, the Netherlands)
Measured: 0 months and 3 months
Change From Baseline Serum Triglycerides at 3 Months
Triglycerides were measured in fasting conditions
Measured: 0 months and 3 months
Change From Baseline Serum Total Cholesterol at 3 Months
Total cholesterol was measured in fasting conditions
Measured: 0 months and 3 months
Change From Baseline Serum LDL-Cholesterol at 3 Months
LDL-cholesterol was measured in fasting conditions
Measured: 0 months and 3 months
Change From Baseline Serum HDL-Cholesterol at 3 Months
HDL-cholesterol was measured in fasting conditions
Measured: 0 months and 3 months
Change From Baseline Serum Uric Acid at 3 Months
Uric acid was measured in fasting conditions
Measured: 0 months and 3 months
Change From Baseline Serum Glucose at 3 Months
Glucose was measured in fasting conditions
Measured: 0 months and 3 months
Change From Baseline Serum Insulin at 3 Months
Insulin was measured in fasting conditions
Measured: 0 months and 3 months
Change From Baseline Serum Glycosylated hemoglobin (HbA1C) at 3 Months
Glycosylated hemoglobin (HbA1C) was measured in fasting conditions
Measured: 0 months and 3 months
Change From Baseline Serum Aspartate Aminotransferase at 3 Months
Aspartate aminotransferase was measured in fasting conditions
Measured: 0 months and 3 months
Change From Baseline Serum Alanine Aminotransferase at 3 Months
Alanine aminotransferase was measured in fasting conditions
Measured: 0 months and 3 months
Change From Baseline Serum Gamma-glutamyltransferase at 3 Months
Gamma glutamyltransferase was measured in fasting conditions
Measured: 0 months and 3 months
Change From Baseline Physical Activity Level at 3 Months
Physical activity was measured by the International Physical Activity Questionnaire (IPAQ)
Measured: 0 months and 3 months
Change From Baseline Dietary Intake at 3 Months
Dietary intake was measured by a 7-day recall
Measured: 0 months and 3 months
Change From Baseline Mediterranean Diet Adherence at 3 Months
Mediterranean diet adherence was measured by the 14-Item Mediterranean Diet Assessment Tool
Measured: 0 months and 3 months
Change From Baseline Health Status at 3 Months
Health status was measured by the SF-36 Health Survey
Measured: 0 months and 3 months
Change From Baseline Gastrointestinal Symptoms at 3 Months
Gastrointestinal symptoms were measured by the gastrointestinal symptoms rating scale, GSRT
Measured: 0 months and 3 months
Change From Baseline Sensory Perception of Precision Foods at 3 Months
Sensory perception of precision foods was measured by the sensory perception questionnaire
Measured: 1 month and 3 months
Food Consumption of the Precision Foods
Food consumption of the precision foods was measured by a food consumption record
Measured: 1 month, 2 months and 3 months
Change From Baseline Risk of Malnutrition at 3 Months
Risk of malnutrition was measured by the Mini Nutritional Assessment (MNA) questionnaire
Measured: 0 months and 3 months
Change From Baseline Cognitive Impairment at 3 Months
Cognitive impairment was measured by the Mini-Mental State Examination (MMSE) questionnaire
Measured: 0 months and 3 months
Change From Baseline Cognitive Function at 3 Months
Cognitive function was measured by the Guttmann NeuroPersonalTrainer platform
Measured: 0 months and 3 months
Baseline Gut Microbiota Composition
Gut Microbiota Composition will be measured using OMNIgene.GUT kits from DNA Genotek
Measured: 0 months
Usability of the digital tools
Usability will be measured using the System Usability Scale (SUS)
Measured: 3 months
Baseline subjective hunger
Visual analogue scale rating in a scale from 0 to 100 mm, for the quantification of the perceived hunger before the experimental food intake
Measured: Baseline
Postprandial subjective hunger
Visual analogue scale rating in a scale from 0 to 100 mm, for the quantification of the perceived hunger measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Measured: Up to 120 minutes
Baseline subjective fullness
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived fullness before the experimental food intake
Measured: Baseline
Postprandial subjective fullness
Visual analogue scale rating in a scale from 0 to 100 mm, for the quantification of the perceived fullness measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Measured: Up to 120 minutes
Baseline subjective satiety
Visual analogue scale rating in a scale from 0 to100 mm for the quantification of the perceived satiety before the experimental food intake.
Measured: Baseline
Postprandial subjective satiety
Visual analogue scale rating in a scale from 0 to100 mm for the quantification of the perceived satiety measured at 15, 30, 45, 60, 90 and 120 minutes after experimental food intake
Measured: Up to 120 minutes
Baseline subjective desire to eat
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived desire to eat before the experimental food intake at baseline.
Measured: Baseline
Postprandial subjective desire to eat
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived desire to eat measured at 15, 30, 45, 60, 90 and 120 minutes after experimental food intake
Measured: Up to 120 minutes
Baseline subjective thirst
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived thirst before the experimental food intake at baseline
Measured: Baseline
Postprandial subjective thirst
Visual analogue scale ratings in a scale from 0 to 100 mm for the quantification the perceived thirst measured at 15, 30, 45, 60, 90 and 120 minutes after experimental food intake
Measured: Up to 120 minutes
Baseline blood glucose concentration
Blood glucose concentration before experimental food intake
Measured: Baseline
Baseline blood insulin concentration
Blood insulin concentration before experimental food intake
Measured: Baseline
Incremental area under the curve (iAUC) for glucose
The incremental area under the curve (AUCi) for glucose was calculated via the geometric sums of the areas of the triangles and trapezoids above the fasting glucose concentration over a 2-h period
Measured: 0,15,30,45,60,90,120
Incremental area under the curve (iAUC) for insulin
The incremental area under the curve (AUCi) for insulin was calculated via the geometric sums of the areas of the triangles and trapezoids above the fasting insulin concentration over a 2-h period
Measured: 0,15,30,45,60,90,120
Baseline blood high density lipoprotein cholesterol (HDL) concentration
Blood high density lipoprotein cholesterol (HDL) concentration before experimental food intake
Measured: Baseline
Baseline blood low density lipoprotein cholesterol (LDL) concentration
Blood low density lipoprotein cholesterol (LDL) concentration before experimental food intake
Measured: Baseline
Baseline blood triglyceride concentration
Blood triglyceride concentration before experimental food intake
Measured: Baseline
Postprandial blood glucose concentration
Blood glucose concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Measured: Up to 120 minutes
Postprandial blood insulin concentration
Blood insulin concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Measured: Up to 120 minutes
Postprandial blood total cholesterol concentration
Blood total cholesterol concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Measured: Up to 120 minutes
Postprandial blood high density lipoprotein cholesterol (HDL) concentration
Blood high density lipoprotein cholesterol (HDL) concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Measured: Up to 120 minutes
Postprandial blood low density lipoprotein cholesterol (LDL) concentration
Blood low density lipoprotein cholesterol (LDL) concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Measured: Up to 120 minutes
Postprandial blood triglyceride concentration
Blood triglyceride concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Measured: Up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start16 Oct 2018
- Primary completion23 Dec 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants are randomly assigned to Control or NUTRIPRECISION strategy.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Itziar Abete, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- Itziar Abete Goñi, PhD, Principal investigator, Centre for Nutrition Research - University of NavarraSantiago Navas Carretero, PhD, Principal investigator, Centre for Nutrition Research - University of NavarraM Ángeles Zulet Alzórriz, Professor, Study director, Centre for Nutrition Research - University of NavarraCarlos Javier González Navarro, PhD, Study director, Centre for Nutrition Research - University of NavarraJ. Alfredo Martínez Hernández, Professor, Study director, Centre for Nutrition Research - University of NavarraViviana Loria Kohen, PhD, Principal investigator, IMDEA FoodAna Ramirez Molina, PhD, Study chair, IMDEA FoodGuillermo Reglero Rada, Professor, Study chair, IMDEA Food
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786925
- Sponsor's protocol ID
- NUTRIPRECISION
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28829397Gonzalez-Muniesa P, Martinez JA. Precision Nutrition and Metabolic Syndrome Management. Nutrients. 2019 Oct 9;11(10):2411. doi: 10.3390/nu11102411.
PubMed 31601025Brooke, 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
Galarregui C, Navas-Carretero S, Zulet MA, Gonzalez-Navarro CJ, Martinez JA, de Cuevillas B, Marcos-Pasero H, Aguilar-Aguilar E, Reglero G, Ramirez de Molina A, Chausa P, Iniesta JM, Hernando ME, Gomez EJ, Garcia-Rudolph A, Garcia-Molina A, Loria-Kohen V, Abete I. Precision nutrition impact on metabolic health and quality of life in aging population after a 3-month intervention: A randomized intervention. J Nutr Health Aging. 2024 Jul;28(7):100289. doi: 10.1016/j.jnha.2024.100289. Epub 2024 Jun 11.
PubMed 38865737
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Improving the Quality of Life of Pre-senior and Senior Populations Based on Precision Nutrition (Proyecto Nutriprecisión)
- ClinicalTrials.gov ID
- NCT04786925
- Acronym / sponsor ID
- NUTRIPRECISION
- Conditions
- Overweight or Obesity
- Keywords
- Obesity, Health status, Insulin resistance, Hypertension, Lipid profile, Gastrointestinal health, Cognitive capacity, Life quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants are randomly assigned to Control or NUTRIPRECISION strategy.
| Arm | Type | Receives |
|---|---|---|
| Control diet | Placebo comparator | Other: Control dietA conventional diet based on the current Spanish Mediterranean dietary guidelines: Spanish Society of Community Nutrition (SENC). |
| Nutriprecision diet | Experimental | Other: Nutriprecision dietA 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women aged 50-80 years
- BMI >27 kg/m2
- One or more of the following risk factors:
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control dietControl 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. | Other | Control diet |
| Nutriprecision dietNutriprecision 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. | Other | Nutriprecision diet |
Primary outcome
Change From Baseline General Health Status at 3 Months
Time frame: 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
55 secondary outcomes
Change From Baseline Weight at 3 Months
Time frame: 0 months and 3 months
Baseline height
Time frame: 0 months
Change From Baseline Body Mass Index at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Fat Mass at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Lean Mass at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Waist Circumference at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Hip Circumference at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Systolic Blood Pressure at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Diastolic Blood Pressure at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Serum Triglycerides at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Serum Total Cholesterol at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Serum LDL-Cholesterol at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Serum HDL-Cholesterol at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Serum Uric Acid at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Serum Glucose at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Serum Insulin at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Serum Glycosylated hemoglobin (HbA1C) at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Serum Aspartate Aminotransferase at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Serum Alanine Aminotransferase at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Serum Gamma-glutamyltransferase at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Physical Activity Level at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Dietary Intake at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Mediterranean Diet Adherence at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Health Status at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Gastrointestinal Symptoms at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Sensory Perception of Precision Foods at 3 Months
Time frame: 1 month and 3 months
Food Consumption of the Precision Foods
Time frame: 1 month, 2 months and 3 months
Change From Baseline Risk of Malnutrition at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Cognitive Impairment at 3 Months
Time frame: 0 months and 3 months
Change From Baseline Cognitive Function at 3 Months
Time frame: 0 months and 3 months
Baseline Gut Microbiota Composition
Time frame: 0 months
Usability of the digital tools
Time frame: 3 months
Baseline subjective hunger
Time frame: Baseline
Postprandial subjective hunger
Time frame: Up to 120 minutes
Baseline subjective fullness
Time frame: Baseline
Postprandial subjective fullness
Time frame: Up to 120 minutes
Baseline subjective satiety
Time frame: Baseline
Postprandial subjective satiety
Time frame: Up to 120 minutes
Baseline subjective desire to eat
Time frame: Baseline
Postprandial subjective desire to eat
Time frame: Up to 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Background: PubMed 28829397de 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.
- Background: PubMed 31601025Gonzalez-Muniesa P, Martinez JA. Precision Nutrition and Metabolic Syndrome Management. Nutrients. 2019 Oct 9;11(10):2411. doi: 10.3390/nu11102411.
- BackgroundBrooke, 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
- Derived from this study: PubMed 38865737Galarregui C, Navas-Carretero S, Zulet MA, Gonzalez-Navarro CJ, Martinez JA, de Cuevillas B, Marcos-Pasero H, Aguilar-Aguilar E, Reglero G, Ramirez de Molina A, Chausa P, Iniesta JM, Hernando ME, Gomez EJ, Garcia-Rudolph A, Garcia-Molina A, Loria-Kohen V, Abete I. Precision nutrition impact on metabolic health and quality of life in aging population after a 3-month intervention: A randomized intervention. J Nutr Health Aging. 2024 Jul;28(7):100289. doi: 10.1016/j.jnha.2024.100289. Epub 2024 Jun 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itziar Abete Goñi, PhD principal investigator
Centre for Nutrition Research - University of Navarra
Santiago Navas Carretero, PhD principal investigator
Centre for Nutrition Research - University of Navarra
M Ángeles Zulet Alzórriz, Professor study director
Centre for Nutrition Research - University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutriprecision diet in people with Overweight or Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline General Health Status at 3 Months (time frame: 0 months and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04786925, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.