Platform for Clinical Trials in Nutrition and Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,963
- 试验地点
- 1
- 主要终点
- Genotypic characterization.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Genotypic characterization.
时间窗: 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.
次要结局
- Changes in cholesterol intake.(At the beginning and before 12 months.)
- Changes in weight.(At the beginning and before 12 months.)
- Changes in fatty acids intake.(At the beginning and before 12 months.)
- Changes in nutritional quality of diet: Healthy Eating Index(At the beginning and before 12 months.)
- Changes in total daily energy intake (TEI).(At the beginning and before 12 months.)
- Changes in fiber intake.(At the beginning and before 12 months.)
- Changes in height.(At the beginning and before 12 months.)
- Changes in body mass index (BMI).(At the beginning and before 12 months.)
- Number of participants with changes in lipid profile.(At the beginning and before 12 months.)
- Changes in macronutrients intake.(At the beginning and before 12 months.)
- Changes in micronutrients intake.(At the beginning and before 12 months.)
- Changes in systolic (SBP) and diastolic blood pressure (DBP).(At the beginning and before 12 months.)
- Number of participants with changes in glycemic profile.(At the beginning and before 12 months.)
- Number of participants with changes in biochemical parameters.(At the beginning and before 12 months.)
- Number of participants with changes in blood clotting and endothelial function.(At the beginning and before 12 months.)
- Changes in sugar intake.(At the beginning and before 12 months.)
- Changes in body composition: fat and lean mass.(At the beginning and before 12 months.)
- Changes in physical activity pattern according to the International Physical Activity Questionnaire (IPAQ).(At the beginning and before 12 months.)
- Changes in waist circumference.(At the beginning and before 12 months.)
- Changes in physical activity pattern according to the Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ).(At the beginning and before 12 months.)
- Number of participants with changes in biochemical parameters associated with inflammation.(At the beginning and before 12 months.)