Healthy AgingOPTIPROTNCT07436936
OPTIPROT, Targeted Precision Nutrition for Protein Needs in Ageing
An observational study of Healthy Aging and Nutritional Status, run by Fundació Eurecat at 1 site in Spain.
Trial summary
This multicenter, cross-sectional observational study aims to use precision nutrition tools to identify metabolic clusters in adults aged 50-75 years, enabling tailored nutritional and protein recommendations based on specific metabolic characteristics. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Nutritional Status, Dietary Protein
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jul 2024to 24 Jan 2025
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The cohort of the proposed study consists of 200 adults aged 50 to 75 years, who are recruited from two different research centers (Eurecat and AZTI) in Spain.
Who may be able to join
- Women or men
- Age: ≥ 50; ≤ 75 years
- BMI: 18.5-35 kg/m² and stable weight for at least 3 months (without weight gain or loss >3 kg).
- Ability to read, write, and speak in Catalan or Spanish.
- Signing of the informed consent form.
Who cannot join
- Age ≤ 49 or ≥ 76 years
- BMI: ≤18.5; ≥ 35
- Pregnant or lactating women
- Presence of chronic or autoimmune disease or metabolic condition that significantly alters nutritional requirements, such as: type I diabetes, celiac disease, inflammatory bowel disease, chronic kidney disease, severe liver disease, uncontrolled thyroid disorders, cancer, food allergies or intolerances, musculoskeletal disorders, moderate or severe cognitive impairment, or immobilization in the last 6 months.
- Alcohol consumption:Men: Consuming 4 or more Standard Drink Units (SDUs)* per day or 28 SDUs per week. Women: Consuming 2 or more Standard Drink Units (SDUs)* per day or 17 SDUs per week.
- Individuals currently participating or who have participated in a clinical trial involving medications or nutritional intervention within the last 30 days before study inclusion.
- Recent use of antibiotics in the last two weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeted Precision Nutrition Strategy to Ensure Age-specific Protein Requirements: a Multicenter Cross-sectional Observational Study (OPTIPROT)
This multicenter, cross-sectional observational study aims to use precision nutrition tools to identify metabolic clusters in adults aged 50-75 years, enabling tailored nutritional and protein recommendations based on specific metabolic characteristics. Conducted at Eurecat-Reus (Catalonia) and AZTI (Bizkaia), the study will enroll 200 participants (75 at Eurecat, 125 at AZTI). Analyses will include metabolomics, gut microbiota profiling, epigenomics, and glycomics, with the goal of refining dietary guidelines and protein intake recommendations to address the specific needs of aging populations.
Read the detailed description
The study hypothesizes that metabolic characterization using precision nutrition tools in adults aged 50 to 75 will enable the identification of clusters with similar metabolic profiles, thereby enhancing our understanding of each group's nutritional needs and facilitating the development of tailored dietary recommendations, particularly regarding protein intake. This multicenter, cross-sectional observational study will recruit 200 participants, 75 at Eurecat-Reus (Catalonia) and 125 at AZTI (Bizkaia), and will integrate metabolic, clinical, anthropometric, lifestyle, dietary, and microbiota data to form these clusters. The primary objective is to establish metabolic profiles and clusters using precision nutrition tools, while secondary objectives include identifying biomarkers associated with health and aging, assessing the relationship between protein intake and metabolic health, and exploring the associations between gut microbiota composition, glycomic patterns, and metabolic status. Participants will attend two visits: an initial visit for eligibility confirmation and informed consent, followed by a second fasting visit for blood sampling, anthropometric measurements, collection of pre-obtained samples, and the administration of validated questionnaires on lifestyle, dietary intake, and physical activity. Ultimately, the integrated analysis of these data will refine nutritional recommendations to better address the specific metabolic needs of each cluster, thereby improving dietary guidance and overall metabolic health in the aging population.
- Conditions
- Healthy Aging, Nutritional Status, Dietary Protein, Muscle Weakness
- Keywords
- precision nutrition, aging, dietary protein intake, gut microbiota, nutritional requirements, metabolomics, epigenomics, glycomics, anthropometry, healthy aging, muscle strength, omics science, muscle mass, Targeted Dietary Intervention, Targeted nutrition
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 200 adults aged 50 to 75 years | 200 adults aged 50 to 75 years, who are recruited from two different research centers (Eurecat and AZTI) in Spain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of nutritional clusters based on metabolic and biomarker profiles
Development of group-based precision nutrition recommendations derived from metabotyping approaches, with special emphasis on protein requirements, by clustering individuals aged 50-75 according to metabolic variables, gut microbiota composition, and classical anthropometric, biochemical, and clinical biomarkers.
Measured: At day 1
Determination of Protein Intake Requirements for Each Cluster
stablishing specific protein intake needs for each identified cluster to optimize nutritional recommendations tailored to the metabolic and physiological characteristics of the target population.
Measured: At day 1
Secondary outcomes (3)
Epigenomic Profile Characterization of a Study Subcohort
Analysis of epigenetic modifications in a subset of participants to refine the precision nutrition algorithm by incorporating epigenomic influences on metabolism and nutrient utilization.
Measured: At day 1
Glycomic Profile Characterization of a Study Subcohort
Examination of glycan composition and glycosylation patterns in a subset of participants to assess their role in metabolic health and further personalize the group-based nutrition strategy.
Measured: At day 1
Validation of Group-Based Precision Nutrition Algorithm
Integration of metabolic, microbiota, and biomarker-based clustering with epigenomic and glycomic data to improve the accuracy of the group-based precision nutrition algorithm.
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start11 Jul 2024
- Primary completion24 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Azti
- Responsible party
- Sponsor
- Investigators
- Noemí Boqué, PhD, Principal investigator, Fundació Eurecat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436936
- Sponsor's protocol ID
- OPTIPROT
- Acronym
- OPTIPROT
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Precision Nutrition Strategy to Ensure Age-specific Protein Requirements: a Multicenter Cross-sectional Observational Study (OPTIPROT)
- ClinicalTrials.gov ID
- NCT07436936
- Acronym / sponsor ID
- OPTIPROT / OPTIPROT
- Conditions
- Healthy Aging, Nutritional Status, Dietary Protein, Muscle Weakness
- Keywords
- precision nutrition, aging, dietary protein intake, gut microbiota, nutritional requirements, metabolomics, epigenomics, glycomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- Fundacion Azti
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 27 Feb 2026 (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.
This multicenter, cross-sectional observational study aims to use precision nutrition tools to identify metabolic clusters in adults aged 50-75 years, enabling tailored nutritional and protein recommendations based on specific metabolic characteristics. Conducted at Eurecat-Reus (Catalonia) and AZTI (Bizkaia), the study will enroll 200 participants (75 at Eurecat, 125 at AZTI). Analyses will include metabolomics, gut microbiota profiling, epigenomics, and glycomics, with the goal of refining dietary guidelines and protein intake recommendations to address the specific needs of aging populations.
Detailed description
The study hypothesizes that metabolic characterization using precision nutrition tools in adults aged 50 to 75 will enable the identification of clusters with similar metabolic profiles, thereby enhancing our understanding of each group's nutritional needs and facilitating the development of tailored dietary recommendations, particularly regarding protein intake. This multicenter, cross-sectional observational study will recruit 200 participants, 75 at Eurecat-Reus (Catalonia) and 125 at AZTI (Bizkaia), and will integrate metabolic, clinical, anthropometric, lifestyle, dietary, and microbiota data to form these clusters. The primary objective is to establish metabolic profiles and clusters using precision nutrition tools, while secondary objectives include identifying biomarkers associated with health and aging, assessing the relationship between protein intake and metabolic health, and exploring the associations between gut microbiota composition, glycomic patterns, and metabolic status. Participants will attend two visits: an initial visit for eligibility confirmation and informed consent, followed by a second fasting visit for blood sampling, anthropometric measurements, collection of pre-obtained samples, and the administration of validated questionnaires on lifestyle, dietary intake, and physical activity. Ultimately, the integrated analysis of these data will refine nutritional recommendations to better address the specific metabolic needs of each cluster, thereby improving dietary guidance and overall metabolic health in the aging population.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 200 adults aged 50 to 75 years | – | –200 adults aged 50 to 75 years, who are recruited from two different research centers (Eurecat and AZTI) in Spain. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort of the proposed study consists of 200 adults aged 50 to 75 years, who are recruited from two different research centers (Eurecat and AZTI) in Spain.
Key inclusion criteria (5 listed)
- Women or men
- Age: ≥ 50; ≤ 75 years
- BMI: 18.5-35 kg/m² and stable weight for at least 3 months (without weight gain or loss >3 kg).
- Ability to read, write, and speak in Catalan or Spanish.
- Signing of the informed consent form.
Key exclusion criteria (7 listed)
- Age ≤ 49 or ≥ 76 years
- BMI: ≤18.5; ≥ 35
- Pregnant or lactating women
- Presence of chronic or autoimmune disease or metabolic condition that significantly alters nutritional requirements, such as: type I diabetes, celiac disease, inflammatory bowel disease, chronic kidney disease, severe liver disease, uncontrolled thyroid disorders, cancer, food allergies or intolerances, musculoskeletal disorders, moderate or severe cognitive impairment, or immobilization in the last 6 months.
- Alcohol consumption:Men: Consuming 4 or more Standard Drink Units (SDUs)* per day or 28 SDUs per week. Women: Consuming 2 or more Standard Drink Units (SDUs)* per day or 17 SDUs per week.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of nutritional clusters based on metabolic and biomarker profiles
Time frame: At day 1
Development of group-based precision nutrition recommendations derived from metabotyping approaches, with special emphasis on protein requirements, by clustering individuals aged 50-75 according to metabolic variables, gut microbiota composition, and classical anthropometric, biochemical, and clinical biomarkers.
Determination of Protein Intake Requirements for Each Cluster
Time frame: At day 1
stablishing specific protein intake needs for each identified cluster to optimize nutritional recommendations tailored to the metabolic and physiological characteristics of the target population.
3 secondary outcomes
Epigenomic Profile Characterization of a Study Subcohort
Time frame: At day 1
Glycomic Profile Characterization of a Study Subcohort
Time frame: At day 1
Validation of Group-Based Precision Nutrition Algorithm
Time frame: At day 1
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 27 Feb 2026.
- Technological Centre of Nutrition and Health. Eurecat\_Reus.Link provided by the sponsor.
- 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.
Noemí Boqué, PhD principal investigator
Fundació Eurecat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aging and Nutritional Status, 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 5 inclusion and 7 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 27 Feb 2026. 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?
Identification of nutritional clusters based on metabolic and biomarker profiles (time frame: At day 1). The study lists 2 primary outcomes in all. 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 27 Feb 2026.