Karina Rodrigues , Marcela M. Mendes , Lana Pacheco Franco-Gedda , Nara R. da Silva , Mariana Oliveira , Flávia C.F. Silva , Flávia Campos Corgosinho , Kristy Soraya Coelho , Franco Maria Lajolo , José M. Aldrighi , Carla M. Prado , Lu Qi , Karani Santhanakrishnan Vimaleswaran , Maria Aderuza Horst
{"title":"基因型引导营养干预减少年轻人心脏代谢危险因素:随机对照试验的研究方案。","authors":"Karina Rodrigues , Marcela M. Mendes , Lana Pacheco Franco-Gedda , Nara R. da Silva , Mariana Oliveira , Flávia C.F. Silva , Flávia Campos Corgosinho , Kristy Soraya Coelho , Franco Maria Lajolo , José M. Aldrighi , Carla M. Prado , Lu Qi , Karani Santhanakrishnan Vimaleswaran , Maria Aderuza Horst","doi":"10.1016/j.clnesp.2025.07.008","DOIUrl":null,"url":null,"abstract":"<div><h3>Background & aims</h3><div>Cardiometabolic diseases (CMD), including cardiovascular disease, obesity and diabetes, are major public health challenges influenced by lifestyle factors (e.g., diet), vitamin D status, and genetic predisposition. Single nucleotide polymorphisms (SNPs) contribute to genetic risk scores for CMD-related traits (M-GRS) and recent research suggests that genotype-based nutritional interventions have the potential to reduce these risks. This study aims to evaluate the effectiveness of genotype-guided nutritional interventions versus standard dietary recommendations in young adults.</div></div><div><h3>Methods</h3><div>This 12-month study includes a 6-month intervention phase and a 6-month free-living phase. Data will be collected at baseline, 3, 6 and 12 months. We plan to recruit young adults (aged 23–29) previously genotyped from the Obesity, Lifestyle, and Diabetes in Brazil (BOLD) study and randomized by BMI, sex, and M-GRS based on 34 SNPs. The control group will follow a standard Brazilian diet with CMD-related recommendations and 1000 IU of vitamin D3 daily. The personalized intervention group will receive a genotype-guided dietary plan based on gene–diet interactions for SNPs in the M-GRS, along with personalized vitamin D3 supplementation (1000 or 4000 IU) based on their genetic risk for deficiency (D-GRS). Body composition, biochemical markers and metabolomics will be assessed, with the reduction in body fat percentage as the primary outcome.</div></div><div><h3>Discussion</h3><div>This study will contribute to precision nutrition by assessing genotype-guided dietary recommendations for CMD risk management, potentially demonstrating how genetic information can optimize dietary interventions and reduce CMD burdens, improving overall health outcomes.</div></div><div><h3>Trial registration</h3><div>Brazilian Registry of Clinical Trials: RBR-7b43sfr <span><span>http://ensaiosclinicos.gov.br/rg/RBR-7b43sfr</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10352,"journal":{"name":"Clinical nutrition ESPEN","volume":"69 ","pages":"Pages 196-206"},"PeriodicalIF":2.6000,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A genotype-guided nutritional intervention to reduce cardiometabolic risk factors in young adults: Study protocol for a randomized controlled trial\",\"authors\":\"Karina Rodrigues , Marcela M. 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This study aims to evaluate the effectiveness of genotype-guided nutritional interventions versus standard dietary recommendations in young adults.</div></div><div><h3>Methods</h3><div>This 12-month study includes a 6-month intervention phase and a 6-month free-living phase. Data will be collected at baseline, 3, 6 and 12 months. We plan to recruit young adults (aged 23–29) previously genotyped from the Obesity, Lifestyle, and Diabetes in Brazil (BOLD) study and randomized by BMI, sex, and M-GRS based on 34 SNPs. The control group will follow a standard Brazilian diet with CMD-related recommendations and 1000 IU of vitamin D3 daily. The personalized intervention group will receive a genotype-guided dietary plan based on gene–diet interactions for SNPs in the M-GRS, along with personalized vitamin D3 supplementation (1000 or 4000 IU) based on their genetic risk for deficiency (D-GRS). 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A genotype-guided nutritional intervention to reduce cardiometabolic risk factors in young adults: Study protocol for a randomized controlled trial
Background & aims
Cardiometabolic diseases (CMD), including cardiovascular disease, obesity and diabetes, are major public health challenges influenced by lifestyle factors (e.g., diet), vitamin D status, and genetic predisposition. Single nucleotide polymorphisms (SNPs) contribute to genetic risk scores for CMD-related traits (M-GRS) and recent research suggests that genotype-based nutritional interventions have the potential to reduce these risks. This study aims to evaluate the effectiveness of genotype-guided nutritional interventions versus standard dietary recommendations in young adults.
Methods
This 12-month study includes a 6-month intervention phase and a 6-month free-living phase. Data will be collected at baseline, 3, 6 and 12 months. We plan to recruit young adults (aged 23–29) previously genotyped from the Obesity, Lifestyle, and Diabetes in Brazil (BOLD) study and randomized by BMI, sex, and M-GRS based on 34 SNPs. The control group will follow a standard Brazilian diet with CMD-related recommendations and 1000 IU of vitamin D3 daily. The personalized intervention group will receive a genotype-guided dietary plan based on gene–diet interactions for SNPs in the M-GRS, along with personalized vitamin D3 supplementation (1000 or 4000 IU) based on their genetic risk for deficiency (D-GRS). Body composition, biochemical markers and metabolomics will be assessed, with the reduction in body fat percentage as the primary outcome.
Discussion
This study will contribute to precision nutrition by assessing genotype-guided dietary recommendations for CMD risk management, potentially demonstrating how genetic information can optimize dietary interventions and reduce CMD burdens, improving overall health outcomes.
Trial registration
Brazilian Registry of Clinical Trials: RBR-7b43sfr http://ensaiosclinicos.gov.br/rg/RBR-7b43sfr.
期刊介绍:
Clinical Nutrition ESPEN is an electronic-only journal and is an official publication of the European Society for Clinical Nutrition and Metabolism (ESPEN). Nutrition and nutritional care have gained wide clinical and scientific interest during the past decades. The increasing knowledge of metabolic disturbances and nutritional assessment in chronic and acute diseases has stimulated rapid advances in design, development and clinical application of nutritional support. The aims of ESPEN are to encourage the rapid diffusion of knowledge and its application in the field of clinical nutrition and metabolism. Published bimonthly, Clinical Nutrition ESPEN focuses on publishing articles on the relationship between nutrition and disease in the setting of basic science and clinical practice. Clinical Nutrition ESPEN is available to all members of ESPEN and to all subscribers of Clinical Nutrition.