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Healthy VolunteersGENYALPlatformNCT04067921

Platform for Clinical Trials in Nutrition and Health

An observational study of Healthy Volunteers, run by IMDEA Food at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Healthy Volunteers
How many people
1,963 participants
Where
1 siteSpain
Study dates
11 Nov 2011to 28 Mar 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 18 to 70 years
  • All sexes
  • Adult, Older adult

Study population: Free-living adults aged from 18 to 70 years and residents of Spain.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • IMDEA Food

    Madrid, 28049

Other trials in Spain

About this study

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.

Keywords
Precision Nutrition, Nutritional Genetics, Nutritional Genomics, Polymorphisms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Genotypic characterization.

    Genomic DNA is isolated from a blood sample. Genotyping was performed using the QuantStudio 12 K Flex Real-Time PCR System (Life Technologies Inc., Carlsbad, CA) with a TaqMan OpenArray plates.

    Measured: Baseline.

Secondary outcomes (21)

  1. Changes in total daily energy intake (TEI).

    Dietary intake is collected using a 72-hour food and drink record validated for the Spanish population. The DIAL software (Alce Ingeniería) is used to evaluate the TEI (kcal) of the sample.

    Measured: At the beginning and before 12 months.

  2. Changes in macronutrients intake.

    Dietary intake is collected using a 72-hour food and drink record validated for the Spanish population. The DIAL software (Alce Ingeniería) is used to evaluate the following variables:

    • Carbohydrates (grams per day and percentage of the TEI).
    • Proteins (grams per day and percentage of the TEI).
    • Lipids (grams per day and percentage of the TEI).

    Measured: At the beginning and before 12 months.

  3. Changes in fatty acids intake.

    Dietary intake is collected using a 72-hour food and drink record validated for the Spanish population. The DIAL software (Alce Ingeniería) is used to evaluate the saturated, unsaturated and polyunsaturated fatty acids intake (grams per day and percentage of the TEI).

    Measured: At the beginning and before 12 months.

  4. Changes in cholesterol intake.

    Dietary intake is collected using a 72-hour food and drink record validated for the Spanish population. The DIAL software (Alce Ingeniería) is used to evaluate the cholesterol intake (milligrams per day).

    Measured: At the beginning and before 12 months.

  5. Changes in fiber intake.

    Dietary intake is collected using a 72-hour food and drink record validated for the Spanish population. The DIAL software (Alce Ingeniería) is used to evaluate the fiber intake (grams per day).

    Measured: At the beginning and before 12 months.

  6. Changes in sugar intake.

    Dietary intake is collected using a 72-hour food and drink record validated for the Spanish population. The DIAL software (Alce Ingeniería) is used to evaluate the sugar intake (grams per day and percentage of the TEI).

    Measured: At the beginning and before 12 months.

  7. Changes in micronutrients intake.

    Dietary intake is collected using a 72-hour food and drink record validated for the Spanish population. The DIAL software (Alce Ingeniería) is used to evaluate the intake (grams, milligrams or micrograms, as the case may be) of the following variables:

    • Minerals: Ca, P, Mg, Fe, Zn, I, F, Se.
    • Vitamins: A, D, E, K, B1, B2, B5, B6, B12, biotin, niacin, folate.

    Measured: At the beginning and before 12 months.

  8. Changes in nutritional quality of diet: Healthy Eating Index

    Dietary intake is collected using a 72-hour food and drink record validated for the Spanish population. The DIAL software (Alce Ingeniería) is used to evaluate the nutritional quality of diet according to the Healthy Eating Index (Kennedy et al, 1995).

    Measured: At the beginning and before 12 months.

  9. Changes in height.

    This anthropometric measure (cm) is taken using a Leicester stadiometer (Biological Medical Technology SL, Barcelona, Spain) by trained nutritionists according to standardized procedures.

    Measured: At the beginning and before 12 months.

  10. Changes in body composition: fat and lean mass.

    Fat mass (%) and lean mass (%) are evaluated using a BF511 Body Composition Monitor (Omron Healthcare Co. Ltd., Kyoto, Japan).

    Measured: At the beginning and before 12 months.

  11. Changes in weight.

    Weight (kg) is evaluated using a BF511 Body Composition Monitor (Omron Healthcare Co. Ltd., Kyoto, Japan).

    Measured: At the beginning and before 12 months.

  12. Changes in body mass index (BMI).

    BMI (kg/m^2) is calculated according to the Quetelet Index ((Weight (kg))/〖Height (m)〗^2 ).

    Measured: At the beginning and before 12 months.

  13. Changes in waist circumference.

    Waist circumference (cm) is measured using a Seca 201 nonelastic tape (Quirumed, Valencia, Spain).

    Measured: At the beginning and before 12 months.

  14. Changes in systolic (SBP) and diastolic blood pressure (DBP).

    Both are measured using a Model M3 Automatic Digital Blood Pressure Monitor (Omron Healthcare Co. Ltd., Kyoto, Japan), according to standardized procedures.

    Measured: At the beginning and before 12 months.

  15. Changes in physical activity pattern according to the Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ).

    The validated Spanish version of the MLTPAQ is used to quantitatively measure the average physical activity practice (kcal/day) by the volunteers. Based on the Compendium of physical activities (PA), Energy Expenditure in Physical Activity (EEPA) is estimated as follows: EEPA = I x N x T; where "I" is the degree of intensity for each physical activity in kcal/min; "N", the number of times that physical activity is developed; and "T", the time in minutes spent in each session.

    The MLTPAQ is administered to assess the quality of PA according to their intensity code: low (intensity code of <=4 kcal/min), moderate (4.5-5.5 kcal/min) and high (>=6 kcal/min).

    Measured: At the beginning and before 12 months.

  16. Changes in physical activity pattern according to the International Physical Activity Questionnaire (IPAQ).

    Physical activity (PA) is assessed using the validated Spanish version of the IPAQ.

    The continuous score is expressed as metabolic equivalents (MET)-min per week: MET level x minutes of activity x events per week.

    The pattern of PA is classified into 3 categories in accordance with the intensity:

    • Low: the lowest level of physical activity.
    • Moderate: any one of the following criteria: >=3 days of vigorous activity of at least 20 min/day or >=5 days of moderate-intensity activity or walking of at least 30 min/ day or >=5 days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week.
    • High: any one of the following criteria: vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-min/week or >=7 days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-min/week.

    Measured: At the beginning and before 12 months.

  17. Number of participants with changes in lipid profile.

    The following lipid parameters will be taking into account:

    • Triglycerides (TG)
    • Total Cholesterol (CT)
    • Low Density Lipoprotein (LDL)
    • Very Low Density Lipoprotein (VLDL)
    • High Density Lipoprotein (HDL)
    • CT/HDL ratio
    • LDL/HDL ratio
    • TG/HDL ratio
    • Apolipoprotein B100
    • Apolipoprotein E
    • Plasma free fatty acids (FFAs)

    Measured: At the beginning and before 12 months.

  18. Number of participants with changes in glycemic profile.

    The following glycemic parameters will be taking into account:

    • Glycemia
    • Insulin
    • Homeostasis Model Assessment (HOMA)

    Measured: At the beginning and before 12 months.

  19. Number of participants with changes in biochemical parameters.

    The following biochemical parameters will be taking into account:

    • LDL-ox
    • 8-iso PGF2α

    Measured: At the beginning and before 12 months.

  20. Number of participants with changes in biochemical parameters associated with inflammation.

    The following parameters will be taking into account:

    • PCRu
    • TNFα
    • IL1β
    • VCAM1
    • ICAM
    • TXB2

    Measured: At the beginning and before 12 months.

  21. Number of participants with changes in blood clotting and endothelial function.

    The following parameters will be taking into account:

    • PAI I
    • Fibrinogen

    Measured: At the beginning and before 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start11 Nov 2011
  3. Primary completion28 Mar 2022
  4. Study completion28 Mar 2025 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
1,963 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04067921
Sponsor's protocol ID
CEI 27-666
Acronym
GENYALPlatform
Status last verified
Feb 2024
First submitted
12 Aug 2019
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32325849

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Volunteers, run by IMDEA Food 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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?

Results are not available in the source record.

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?

Genotypic characterization. (time frame: Baseline.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04067921, which also lists 1 linked publication.

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 5 Mar 2024.

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