AgingNUTRIMETNCT05566938
Study to Design a Precision Nutrition Strategy At a Group Level in the Elderly
A study testing Tailored nutritional recommendations for each metabotype in people with Aging, run by Fundació Eurecat at 1 site in Spain.
Trial summary
From a public health point of view, personalized nutritional recommendations, at the individual level, are difficult to achieve in the short-medium term, especially in population segments with less purchasing power. Read more about this study
- Who is it for?
- Ages 66 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Tailored nutritional recommendations for each metabotype
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteSpain
- Study dates
- 5 Sep 2022to 3 Sep 2023
- 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 66 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women over 65 years of age
- Have or have access (caregiver, family member) to a smartphone or tablet with Android operating system version 6 (API 23) or higher, with internet access
- Have the signed informed consent before the initial screening visit
Who cannot join
- Have food allergies or intolerances
- Have diarrhea
- People with irritable bowel syndrome or inflammatory bowel disease.
- Present some severe chronic pathology with clinical manifestations such as cardiovascular disease, coronary disease, chronic kidney disease or cancer.
- Participate or have participated in another clinical study or nutritional intervention in the 30 days prior to inclusion in the study.
- Following a prescribed diet for any reason, including weight loss, in the past month.
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- Recent use of antibiotics in the last two weeks.
- Consumption of prebiotics and/or probiotics in the 30 days prior to the study
- Have a BMI <18.5 kg/m2
- Smoke more than 10 cigarettes a day
- Consume more than 14 standard drinking units (SDUs) of alcoholic beverages per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Design a Tailored Precision Nutrition Strategy Based on Metabotypes in the Elderly
From a public health point of view, personalized nutritional recommendations, at the individual level, are difficult to achieve in the short-medium term, especially in population segments with less purchasing power. Therefore, a more realistic vision in the short term and with a more favourable cost/effectiveness ratio consists of carrying out dietary advice at the group level through the identification of metabotypes, which can be defined as groups of individuals with similar metabolic profiles. The application of tailored precision nutrition aimed at the elderly is detected as a strategy to understand the different alterations associated to aging and to design innovative nutritional interventions that address this physiological process, favouring a healthy ageing.
Read the detailed description
The main objective of this study is to design a precision nutrition strategy at the group level in older people, based on the identification of metabotypes and enterotypes, and combining complementary variables such as anthropometric, biochemical and clinical biomarkers.
The specific objectives of the study are:
- To identify metabotypes (clusters) in a cohort of older people, through an integrated approach of metabolomics, intestinal microbiota and anthropometric, biochemical and clinical biomarkers.
- To develop digital tools, integrated into a mobile application, that allow the precise assignment of automated nutritional recommendations at the group level based on the metabotypes obtained, as well as promoting the adoption of new dietary habits through diet self-monitoring.
- To evaluate the concordance of the nutritional recommendations generated at the group level by means of an automated system with the recommendations elaborated at the individual level by a nutritionist.
A total of 150 elderly people (age> 65 years) will be recruited. In order to identify the metabotypes, blood, urine and feces will be collected to determine biomarkers of inflammation, glucose metabolism, lipid metabolism, oxidative stress, bone health, sarcopenia, clinical biomarkers, intestinal microbiota and metabolomics. In addition, the following measures will be analyzed: food intake (3-day dietary records), anthropometric variables, blood pressure, bowel movement and stool consistency, diagnosis of dysphagia and sarcopenia, and measurement of frailty, muscle strength and physical performance. By using clustering tools, groups with similar metabolism and microbiota profiles (metabotypes and enterotypes) will be defined and the variables that contribute most significantly to the differentiation between clusters will be determined. The nutritionist team will elaborate tailored dietary advice for each cluster.
In parallel, mobile health tools will be developed in order to allow the volunteers to recieve and check these nutritional recommendations, and to facilitate behaviour change through dietary self-monitoring.
The volunteers will also recieve personalized nutritional recommendations individually. The tailored nutritional recommendations given at the group level (metabotypes) will be compared with the individually personalized recommendations. The objective is to obtain a high coincidence (> 80%) in the dietary recommendations between these two approaches.
The total duration of the study for each volunteer will be 14 months. During this period, participants will make 4 visits:
- A pre-selection visit (to check inclusion/exclusion criteria) (V0; day 1) and, if the inclusion criteria are met,
- A study visit (V1; day 5) in which samples will be collected from faeces, urine and blood; and the following will be measured: food intake (3-day dietary record), anthropometry, body composition, blood pressure, frailty, muscle strength, physical performance, bowel movement and stool consistency, diagnosis of dysphagia and sarcopenia.
- A study visit (V2; day 30) in which individualized nutritional recommendations will be provided to the volunteer by the nutritionist.
- A telephonic study visit (V3; month 14) in which an explanation of the instructions to download and run the App through the volunteer will have access to targeted dietary recommendations (according to the assigned cluster) will be given.
- Conditions
- Aging
- Being tested
- Tailored nutritional recommendations for each metabotype
- Keywords
- metabotypes, clusters, tailored nutrition, mhealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored nutritional recommendations for each metabotypeOther
Tailored nutritional recommendations for each metabotype detected (at the group level), that will be delivered through a mobile application. Moreover, each volunteer will recieve individualized nutritional recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Tailored nutritional recommendations for each metabotype | Other | Volunteers that will be clustered into metabotypes and will recieve tailored nutritional recommendations according to their metabotype. Receives: Other: Tailored nutritional recommendations for each metabotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between the nutritional recommendations generated at the group level and at the individual level
To assess the concordance between the two methods used (group vs individual nutritional recommendations) the following will be considered:
- How many of the nutrients identified as main objectives match between the 2 methods (in percentage)
- How many nutritional recommendations generated by the 2 methods agree with each other (in percentage)
Measured: At the final point (month 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start5 Sep 2022
- Primary completion3 Sep 2023
- Study completion3 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- Consorci Sanitari del Maresme, Consorcio Centro de Investigación Biomédica en Red (CIBER), Bana Hosting, Sixtemia
- Responsible party
- Sponsor
- Investigators
- Pere Clavé, MD, PhD, Principal investigator, Consorci Sanitari del Maresme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566938
- Sponsor's protocol ID
- NUTRIMET
- Acronym
- NUTRIMET
- Status last verified
- Mar 2025
- First submitted
- 29 Sep 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Design a Tailored Precision Nutrition Strategy Based on Metabotypes in the Elderly
- ClinicalTrials.gov ID
- NCT05566938
- Acronym / sponsor ID
- NUTRIMET / NUTRIMET
- Conditions
- Aging
- Keywords
- metabotypes, clusters, tailored nutrition, mhealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- Consorci Sanitari del Maresme, Consorcio Centro de Investigación Biomédica en Red (CIBER), Bana Hosting, Sixtemia
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 3 Sep 2023 (actual)
- Study completion
- 3 Sep 2023 (actual)
- First posted
- 5 Oct 2022 (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.
From a public health point of view, personalized nutritional recommendations, at the individual level, are difficult to achieve in the short-medium term, especially in population segments with less purchasing power. Therefore, a more realistic vision in the short term and with a more favourable cost/effectiveness ratio consists of carrying out dietary advice at the group level through the identification of metabotypes, which can be defined as groups of individuals with similar metabolic profiles. The application of tailored precision nutrition aimed at the elderly is detected as a strategy to understand the different alterations associated to aging and to design innovative nutritional interventions that address this physiological process, favouring a healthy ageing.
Detailed description
The main objective of this study is to design a precision nutrition strategy at the group level in older people, based on the identification of metabotypes and enterotypes, and combining complementary variables such as anthropometric, biochemical and clinical biomarkers.
The specific objectives of the study are:
- To identify metabotypes (clusters) in a cohort of older people, through an integrated approach of metabolomics, intestinal microbiota and anthropometric, biochemical and clinical biomarkers.
- To develop digital tools, integrated into a mobile application, that allow the precise assignment of automated nutritional recommendations at the group level based on the metabotypes obtained, as well as promoting the adoption of new dietary habits through diet self-monitoring.
- To evaluate the concordance of the nutritional recommendations generated at the group level by means of an automated system with the recommendations elaborated at the individual level by a nutritionist.
A total of 150 elderly people (age> 65 years) will be recruited. In order to identify the metabotypes, blood, urine and feces will be collected to determine biomarkers of inflammation, glucose metabolism, lipid metabolism, oxidative stress, bone health, sarcopenia, clinical biomarkers, intestinal microbiota and metabolomics. In addition, the following measures will be analyzed: food intake (3-day dietary records), anthropometric variables, blood pressure, bowel movement and stool consistency, diagnosis of dysphagia and sarcopenia, and measurement of frailty, muscle strength and physical performance. By using clustering tools, groups with similar metabolism and microbiota profiles (metabotypes and enterotypes) will be defined and the variables that contribute most significantly to the differentiation between clusters will be determined. The nutritionist team will elaborate tailored dietary advice for each cluster.
In parallel, mobile health tools will be developed in order to allow the volunteers to recieve and check these nutritional recommendations, and to facilitate behaviour change through dietary self-monitoring.
The volunteers will also recieve personalized nutritional recommendations individually. The tailored nutritional recommendations given at the group level (metabotypes) will be compared with the individually personalized recommendations. The objective is to obtain a high coincidence (> 80%) in the dietary recommendations between these two approaches.
The total duration of the study for each volunteer will be 14 months. During this period, participants will make 4 visits:
- A pre-selection visit (to check inclusion/exclusion criteria) (V0; day 1) and, if the inclusion criteria are met,
- A study visit (V1; day 5) in which samples will be collected from faeces, urine and blood; and the following will be measured: food intake (3-day dietary record), anthropometry, body composition, blood pressure, frailty, muscle strength, physical performance, bowel movement and stool consistency, diagnosis of dysphagia and sarcopenia.
- A study visit (V2; day 30) in which individualized nutritional recommendations will be provided to the volunteer by the nutritionist.
- A telephonic study visit (V3; month 14) in which an explanation of the instructions to download and run the App through the volunteer will have access to targeted dietary recommendations (according to the assigned cluster) will be given.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tailored nutritional recommendations for each metabotype | Other | Other: Tailored nutritional recommendations for each metabotypeVolunteers that will be clustered into metabotypes and will recieve tailored nutritional recommendations according to their metabotype. |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Men and women over 65 years of age
- Have or have access (caregiver, family member) to a smartphone or tablet with Android operating system version 6 (API 23) or higher, with internet access
- Have the signed informed consent before the initial screening visit
Key exclusion criteria (11 listed)
- Have food allergies or intolerances
- Have diarrhea
- People with irritable bowel syndrome or inflammatory bowel disease.
- Present some severe chronic pathology with clinical manifestations such as cardiovascular disease, coronary disease, chronic kidney disease or cancer.
- Participate or have participated in another clinical study or nutritional intervention in the 30 days prior to inclusion in the study.
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 |
|---|---|---|
| Tailored nutritional recommendations for each metabotypeTailored nutritional recommendations for each metabotype detected (at the group level), that will be delivered through a mobile application. Moreover, each volunteer will recieve individualized nutritional recommendations. | Other | Tailored nutritional recommendations for each metabotype |
Primary outcome
Concordance between the nutritional recommendations generated at the group level and at the individual level
Time frame: At the final point (month 14)
To assess the concordance between the two methods used (group vs individual nutritional recommendations) the following will be considered: * How many of the nutrients identified as main objectives match between the 2 methods (in percentage) * How many nutritional recommendations generated by the 2 methods agree with each other (in percentage)
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 12 Mar 2025.
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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.
Pere Clavé, MD, PhD principal investigator
Consorci Sanitari del Maresme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored nutritional recommendations for each metabotype in people with Aging, run by Fundació Eurecat 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 3 inclusion and 11 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 12 Mar 2025. 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. 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?
Concordance between the nutritional recommendations generated at the group level and at the individual level (time frame: At the final point (month 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2025.