Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Platform for Clinical Trials in Nutrition and Health (GENYALPlatform)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067921
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
IMDEA Food

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.


Condition or disease
Healthy Volunteers

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1963 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : November 11, 2011
Estimated Primary Completion Date : February 11, 2020
Estimated Study Completion Date : February 11, 2020



Primary Outcome Measures :
  1. Genotypic characterization. [ Time Frame: Baseline. ]
    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.


Secondary Outcome Measures :
  1. Changes in total daily energy intake (TEI). [ Time Frame: At the beginning and before 12 months. ]
    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.

  2. Changes in macronutrients intake. [ Time Frame: At the beginning and before 12 months. ]

    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).

  3. Changes in fatty acids intake. [ Time Frame: At the beginning and before 12 months. ]
    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).

  4. Changes in cholesterol intake. [ Time Frame: At the beginning and before 12 months. ]
    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).

  5. Changes in fiber intake. [ Time Frame: At the beginning and before 12 months. ]
    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).

  6. Changes in sugar intake. [ Time Frame: At the beginning and before 12 months. ]
    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).

  7. Changes in micronutrients intake. [ Time Frame: At the beginning and before 12 months. ]

    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.

  8. Changes in nutritional quality of diet: Healthy Eating Index [ Time Frame: At the beginning and before 12 months. ]
    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).

  9. Changes in height. [ Time Frame: At the beginning and before 12 months. ]
    This anthropometric measure (cm) is taken using a Leicester stadiometer (Biological Medical Technology SL, Barcelona, Spain) by trained nutritionists according to standardized procedures.

  10. Changes in body composition: fat and lean mass. [ Time Frame: At the beginning and before 12 months. ]
    Fat mass (%) and lean mass (%) are evaluated using a BF511 Body Composition Monitor (Omron Healthcare Co. Ltd., Kyoto, Japan).

  11. Changes in weight. [ Time Frame: At the beginning and before 12 months. ]
    Weight (kg) is evaluated using a BF511 Body Composition Monitor (Omron Healthcare Co. Ltd., Kyoto, Japan).

  12. Changes in body mass index (BMI). [ Time Frame: At the beginning and before 12 months. ]
    BMI (kg/m^2) is calculated according to the Quetelet Index ((Weight (kg))/〖Height (m)〗^2 ).

  13. Changes in waist circumference. [ Time Frame: At the beginning and before 12 months. ]
    Waist circumference (cm) is measured using a Seca 201 nonelastic tape (Quirumed, Valencia, Spain).

  14. Changes in systolic (SBP) and diastolic blood pressure (DBP). [ Time Frame: At the beginning and before 12 months. ]
    Both are measured using a Model M3 Automatic Digital Blood Pressure Monitor (Omron Healthcare Co. Ltd., Kyoto, Japan), according to standardized procedures.

  15. Changes in physical activity pattern according to the Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ). [ Time Frame: At the beginning and before 12 months. ]

    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).


  16. Changes in physical activity pattern according to the International Physical Activity Questionnaire (IPAQ). [ Time Frame: At the beginning and before 12 months. ]

    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.

  17. Number of participants with changes in lipid profile. [ Time Frame: At the beginning and before 12 months. ]

    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)

  18. Number of participants with changes in glycemic profile. [ Time Frame: At the beginning and before 12 months. ]

    The following glycemic parameters will be taking into account:

    • Glycemia
    • Insulin
    • Homeostasis Model Assessment (HOMA)

  19. Number of participants with changes in biochemical parameters. [ Time Frame: At the beginning and before 12 months. ]

    The following biochemical parameters will be taking into account:

    • LDL-ox
    • 8-iso PGF2α

  20. Number of participants with changes in biochemical parameters associated with inflammation. [ Time Frame: At the beginning and before 12 months. ]

    The following parameters will be taking into account:

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

  21. Number of participants with changes in blood clotting and endothelial function. [ Time Frame: At the beginning and before 12 months. ]

    The following parameters will be taking into account:

    • PAI I
    • Fibrinogen



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Free-living adults aged from 18 to 70 years and residents of Spain.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067921


Contacts
Layout table for location contacts
Contact: Viviana Loria-Kohen, PhD +34917278100 ext 109 viviana.loria@imdea.org

Locations
Layout table for location information
Spain
IMDEA Food Recruiting
Madrid, Spain, 28049
Contact: Viviana Loria-Kohen, PhD    +34917278100 ext 109    viviana.loria@imdea.org   
Principal Investigator: Viviana Loria-Kohen, PhD         
Sub-Investigator: Elena Aguilar-Aguilar, PhD         
Sub-Investigator: Helena Marcos-Pasero, PhD student         
Sub-Investigator: Isabel Espinosa-Salinas, PhD         
Sub-Investigator: Susana Molina, PhD         
Sub-Investigator: Gonzalo Colmenarejo, PhD         
Sponsors and Collaborators
IMDEA Food
Investigators
Layout table for investigator information
Study Director: Ana Ramírez, PhD IMDEA Food
Study Director: Guillermo Reglero, Prof. PhD IMDEA Food
Principal Investigator: Viviana Loria-Kohen, PhD IMDEA Food
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: IMDEA Food
ClinicalTrials.gov Identifier: NCT04067921    
Other Study ID Numbers: CEI 27-666
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Keywords provided by IMDEA Food:
Precision Nutrition
Nutritional Genetics
Nutritional Genomics
Polymorphisms