Delyse SY Tien , Meghan Hockey , Daniel So , Jordan Stanford , Erin D Clarke , Clare E Collins , Heidi M Staudacher
{"title":"关于在营养研究中设计、开展和报告喂养试验的建议。","authors":"Delyse SY Tien , Meghan Hockey , Daniel So , Jordan Stanford , Erin D Clarke , Clare E Collins , Heidi M Staudacher","doi":"10.1016/j.advnut.2024.100283","DOIUrl":null,"url":null,"abstract":"<div><div>Double-blind, placebo-controlled, randomized controlled trials are the gold standard for clinical trials in nutrition science. For trials of whole diets, dietary counseling is advantageous as they offer clinical translatability although can vary in the fidelity of the intended intervention from participant to participant and across studies. Feeding trials, in which most or all food is provided, offer high precision and can provide proof-of-concept evidence that a dietary intervention is efficacious and can also better evaluate the effect of known quantities of foods and nutrients on physiology. However, they come with additional methodological complexities. Feeding trials also call for a variety of unique methodological considerations, not least of which relate to the design and delivery of diets to participants. This review aims to provide a comprehensive summary of recommendations for design and conduct of feeding trials, encompassing domiciled and nondomiciled feeding trials. Several pertinent aspects of trial design and methodology are discussed, including defining the study population to maximize retention, safety, and generalizability of findings, recommendations for design of control interventions and optimizing blinding, and specific considerations for clinical populations. A detailed stepwise process for menu design, development, validation, and delivery are also presented. These recommendations aim to facilitate methodologic consistency and execution of high-quality feeding trials, ultimately facilitating improved understanding of the role of diet in treating disease and the underpinning mechanisms.</div></div>","PeriodicalId":7349,"journal":{"name":"Advances in Nutrition","volume":"15 10","pages":"Article 100283"},"PeriodicalIF":8.0000,"publicationDate":"2024-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Recommendations for Designing, Conducting, and Reporting Feeding Trials in Nutrition Research\",\"authors\":\"Delyse SY Tien , Meghan Hockey , Daniel So , Jordan Stanford , Erin D Clarke , Clare E Collins , Heidi M Staudacher\",\"doi\":\"10.1016/j.advnut.2024.100283\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><div>Double-blind, placebo-controlled, randomized controlled trials are the gold standard for clinical trials in nutrition science. For trials of whole diets, dietary counseling is advantageous as they offer clinical translatability although can vary in the fidelity of the intended intervention from participant to participant and across studies. Feeding trials, in which most or all food is provided, offer high precision and can provide proof-of-concept evidence that a dietary intervention is efficacious and can also better evaluate the effect of known quantities of foods and nutrients on physiology. However, they come with additional methodological complexities. Feeding trials also call for a variety of unique methodological considerations, not least of which relate to the design and delivery of diets to participants. This review aims to provide a comprehensive summary of recommendations for design and conduct of feeding trials, encompassing domiciled and nondomiciled feeding trials. Several pertinent aspects of trial design and methodology are discussed, including defining the study population to maximize retention, safety, and generalizability of findings, recommendations for design of control interventions and optimizing blinding, and specific considerations for clinical populations. A detailed stepwise process for menu design, development, validation, and delivery are also presented. These recommendations aim to facilitate methodologic consistency and execution of high-quality feeding trials, ultimately facilitating improved understanding of the role of diet in treating disease and the underpinning mechanisms.</div></div>\",\"PeriodicalId\":7349,\"journal\":{\"name\":\"Advances in Nutrition\",\"volume\":\"15 10\",\"pages\":\"Article 100283\"},\"PeriodicalIF\":8.0000,\"publicationDate\":\"2024-08-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in Nutrition\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2161831324001170\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"NUTRITION & DIETETICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Nutrition","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2161831324001170","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"NUTRITION & DIETETICS","Score":null,"Total":0}
Recommendations for Designing, Conducting, and Reporting Feeding Trials in Nutrition Research
Double-blind, placebo-controlled, randomized controlled trials are the gold standard for clinical trials in nutrition science. For trials of whole diets, dietary counseling is advantageous as they offer clinical translatability although can vary in the fidelity of the intended intervention from participant to participant and across studies. Feeding trials, in which most or all food is provided, offer high precision and can provide proof-of-concept evidence that a dietary intervention is efficacious and can also better evaluate the effect of known quantities of foods and nutrients on physiology. However, they come with additional methodological complexities. Feeding trials also call for a variety of unique methodological considerations, not least of which relate to the design and delivery of diets to participants. This review aims to provide a comprehensive summary of recommendations for design and conduct of feeding trials, encompassing domiciled and nondomiciled feeding trials. Several pertinent aspects of trial design and methodology are discussed, including defining the study population to maximize retention, safety, and generalizability of findings, recommendations for design of control interventions and optimizing blinding, and specific considerations for clinical populations. A detailed stepwise process for menu design, development, validation, and delivery are also presented. These recommendations aim to facilitate methodologic consistency and execution of high-quality feeding trials, ultimately facilitating improved understanding of the role of diet in treating disease and the underpinning mechanisms.
期刊介绍:
Advances in Nutrition (AN/Adv Nutr) publishes focused reviews on pivotal findings and recent research across all domains relevant to nutritional scientists and biomedical researchers. This encompasses nutrition-related research spanning biochemical, molecular, and genetic studies using experimental animal models, domestic animals, and human subjects. The journal also emphasizes clinical nutrition, epidemiology and public health, and nutrition education. Review articles concentrate on recent progress rather than broad historical developments.
In addition to review articles, AN includes Perspectives, Letters to the Editor, and supplements. Supplement proposals require pre-approval by the editor before submission. The journal features reports and position papers from the American Society for Nutrition, summaries of major government and foundation reports, and Nutrient Information briefs providing crucial details about dietary requirements, food sources, deficiencies, and other essential nutrient information. All submissions with scientific content undergo peer review by the Editors or their designees prior to acceptance for publication.