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OPTIPROT, Targeted Precision Nutrition for Protein Needs in Ageing

Targeted Precision Nutrition Strategy to Ensure Age-specific Protein Requirements: a Multicenter Cross-sectional Observational Study (OPTIPROT)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07436936
Acronym
OPTIPROT
Enrollment
200
Registered
2026-02-27
Start date
2024-07-11
Completion date
2025-01-24
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Protein, Healthy Aging, Muscle Weakness, Nutritional Status

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

Brief 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. 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.

Interventions

None listed

Sponsors

Fundació Eurecat
Lead SponsorOTHER
Fundacion Azti
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Identification of nutritional clusters based on metabolic and biomarker profilesAt day 1Development 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 ClusterAt day 1stablishing specific protein intake needs for each identified cluster to optimize nutritional recommendations tailored to the metabolic and physiological characteristics of the target population.

Secondary

MeasureTime frameDescription
Epigenomic Profile Characterization of a Study SubcohortAt day 1Analysis of epigenetic modifications in a subset of participants to refine the precision nutrition algorithm by incorporating epigenomic influences on metabolism and nutrient utilization.
Glycomic Profile Characterization of a Study SubcohortAt day 1Examination 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.
Validation of Group-Based Precision Nutrition AlgorithmAt day 1Integration of metabolic, microbiota, and biomarker-based clustering with epigenomic and glycomic data to improve the accuracy of the group-based precision nutrition algorithm.

Countries

Spain

Contacts

PRINCIPAL_INVESTIGATORNoemí Boqué, PhD

Fundació Eurecat

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026