Platform for Clinical Trials in Nutrition and Health

Study Overview
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Brief Summary
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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
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Healthy Volunteers

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the beginning and before 12 months. | 
| 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). | At the beginning and before 12 months. | 
| 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). | At the beginning and before 12 months. | 
| 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). | At the beginning and before 12 months. | 
| 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). | At the beginning and before 12 months. | 
| 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). | At the beginning and before 12 months. | 
| 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. | At the beginning and before 12 months. | 
| 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). | At the beginning and before 12 months. | 
| 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. | At the beginning and before 12 months. | 
| 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). | At the beginning and before 12 months. | 
| Changes in weight. | Weight (kg) is evaluated using a BF511 Body Composition Monitor (Omron Healthcare Co. Ltd., Kyoto, Japan). | At the beginning and before 12 months. | 
| Changes in body mass index (BMI). | BMI (kg/m^2) is calculated according to the Quetelet Index ((Weight (kg))/〖Height (m)〗^2 ). | At the beginning and before 12 months. | 
| Changes in waist circumference. | Waist circumference (cm) is measured using a Seca 201 nonelastic tape (Quirumed, Valencia, Spain). | At the beginning and before 12 months. | 
| 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. | At the beginning and before 12 months. | 
| 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). | At the beginning and before 12 months. | 
| 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. | At the beginning and before 12 months. | 
| 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) | At the beginning and before 12 months. | 
| Number of participants with changes in glycemic profile. | The following glycemic parameters will be taking into account: Glycemia Insulin Homeostasis Model Assessment (HOMA) | At the beginning and before 12 months. | 
| Number of participants with changes in biochemical parameters. | The following biochemical parameters will be taking into account: LDL-ox 8-iso PGF2α | At the beginning and before 12 months. | 
| 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 | At the beginning and before 12 months. | 
| Number of participants with changes in blood clotting and endothelial function. | The following parameters will be taking into account: PAI I Fibrinogen | At the beginning and before 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Precision Nutrition, Nutritional Genetics, Nutritional Genomics, Polymorphisms