Clinical trial NCT04067921: Platform for Clinical Trials in Nutrition and Health
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy Volunteers
Keywords: Precision Nutrition
Nutritional Genetics
Nutritional Genomics
Polymorphisms
Lead sponsor: IMDEA Food
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 1963
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Free-living adults aged from 18 to 70 years and residents of Spain.

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.


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.

Primary outcomes:
measure: Genotypic characterization.
timeFrame: Baseline.
Secondary outcomes:
measure: Changes in total daily energy intake (TEI).
timeFrame: At the beginning and before 12 months.
measure: Changes in macronutrients intake.
timeFrame: At the beginning and before 12 months.
measure: Changes in fatty acids intake.
timeFrame: At the beginning and before 12 months.
measure: Changes in cholesterol intake.
timeFrame: At the beginning and before 12 months.
measure: Changes in fiber intake.
timeFrame: At the beginning and before 12 months.
measure: Changes in sugar intake.
timeFrame: At the beginning and before 12 months.
measure: Changes in micronutrients intake.
timeFrame: At the beginning and before 12 months.
measure: Changes in nutritional quality of diet: Healthy Eating Index
timeFrame: At the beginning and before 12 months.
measure: Changes in height.
timeFrame: At the beginning and before 12 months.
measure: Changes in body composition: fat and lean mass.
timeFrame: At the beginning and before 12 months.
measure: Changes in weight.
timeFrame: At the beginning and before 12 months.
measure: Changes in body mass index (BMI).
timeFrame: At the beginning and before 12 months.
measure: Changes in waist circumference.
timeFrame: At the beginning and before 12 months.
measure: Changes in systolic (SBP) and diastolic blood pressure (DBP).
timeFrame: At the beginning and before 12 months.
measure: Changes in physical activity pattern according to the Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ).
timeFrame: At the beginning and before 12 months.
measure: Changes in physical activity pattern according to the International Physical Activity Questionnaire (IPAQ).
timeFrame: At the beginning and before 12 months.
measure: Number of participants with changes in lipid profile.
timeFrame: At the beginning and before 12 months.
measure: Number of participants with changes in glycemic profile.
timeFrame: At the beginning and before 12 months.
measure: Number of participants with changes in biochemical parameters.
timeFrame: At the beginning and before 12 months.
measure: Number of participants with changes in biochemical parameters associated with inflammation.
timeFrame: At the beginning and before 12 months.
measure: Number of participants with changes in blood clotting and endothelial function.
timeFrame: At the beginning and before 12 months.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IMDEA Food
Study officials:
affiliation: IMDEA Food
name: Ana Ramírez, PhD
role: STUDY_DIRECTOR
affiliation: IMDEA Food
name: Guillermo Reglero, Prof. PhD
role: STUDY_DIRECTOR
affiliation: IMDEA Food
name: Viviana Loria-Kohen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.