Platform for Clinical Trials in Nutrition and Health

NCT ID: NCT04067921

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1963 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-11
• Study Completion Date: 2025-03-28

Brief Summary

Despite the known link between dietary patterns and disease, it has been observed that the specific response of each individual to dietary components highly varied, and this may limit the impact of the nutritional interventions to improve public health. These observations provided the basis to the development of the Nutritional Genomics at the beginning of the 90s, which main goal was to study the interaction between dietary factors and the genome that modulate phenotypic expression. From this idea, in the recent years, Precision Nutrition has been emerged as a therapeutic approach that takes into account all individual's characteristics to develop targeted nutritional advices. The main goal of Precision Nutrition is to maintain or improve health by using genetics, phenotypic, clinical, dietary and other information to provide more precise and more efficacious personalized healthy eating advice and to motivate appropriate dietary changes. However, all the genotype-dependent advice must be based on scientific evidence. Most of the available evidence in support of personalized nutrition has come from observational studies with risk factors as outcomes, and it was needed randomized controlled trials using clinical endpoints to ratify these results.

The main objective of the Platform for Clinical Trials in Nutrition and Health (GENYAL) is to contribute to Precision Nutrition Research by the construction, for the first time, of a human gene and phenotype database to be used in: 1) The evaluation of the efficacy of different foods, functional foods and bioactive compounds capsules on general population and by genotypes and 2) The performance of nutritional genetics and nutrigenomics studies. For that purposes, GENYAL has a permanent recruitment of volunteers, which are phenotypically and genotypically characterized, and give consent to be contacted to perform clinical trials and nutritional intervention studies. Therefore, GENYAL may help to increase the existing knowledge for moving along to Nutritional Genomics research to its practical application in Precision Nutrition; contributing in the improvement in health and disease prevention through dietary recommendations based on the genome.

Conditions

Healthy Volunteers

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Free-living adults aged from 18 to 70 years that give written informed consent to be contacted to perform clinical trials and nutritional intervention studies.

Exclusion Criteria

• Suffering from any serious illness (kidney or liver diseases or other condition that affects lifestyle or diet).
• Presenting dementia or impaired cognitive function
• Being pregnant or breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IMDEA Food

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Ramírez, PhD

Role: STUDY_DIRECTOR

IMDEA Food

Guillermo Reglero, Prof. PhD

Role: STUDY_DIRECTOR

IMDEA Food

Viviana Loria-Kohen, PhD

Role: PRINCIPAL_INVESTIGATOR

IMDEA Food

Locations

IMDEA Food

Madrid, , Spain

Countries

Spain

References

Camblor Murube M, Borregon-Rivilla E, Colmenarejo G, Aguilar-Aguilar E, Martinez JA, Ramirez De Molina A, Reglero G, Loria-Kohen V. Polymorphism of CLOCK Gene rs3749474 as a Modulator of the Circadian Evening Carbohydrate Intake Impact on Nutritional Status in an Adult Sample. Nutrients. 2020 Apr 19;12(4):1142. doi: 10.3390/nu12041142.

Reference Type: DERIVED

PMID: 32325849 (View on PubMed)

Other Identifiers

CEI 27-666

Identifier Type: -

Identifier Source: org_study_id