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Completed

NCT Number: NCT07436936

OPTIPROT, Targeted Precision Nutrition for Protein Needs in Ageing

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Epigenomic Profile Characterization of a Study Subcohort

    Time frame: At day 1

    Analysis of epigenetic modifications in a subset of participants to refine the precision nutrition algorithm by incorporating epigenomic influences on metabolism and nutrient utilization.

  2. Glycomic Profile Characterization of a Study Subcohort

    Time frame: At day 1

    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.

  3. Validation of Group-Based Precision Nutrition Algorithm

    Time frame: At day 1

    Integration of metabolic, microbiota, and biomarker-based clustering with epigenomic and glycomic data to improve the accuracy of the group-based precision nutrition algorithm.

Sponsors and collaborators

Lead sponsor

Fundació Eurecat

Other

Collaborators

  • Fundacion Azti

Registry information

Official study title

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

Acronym: OPTIPROT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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