Rationale and design of the frequency of eating and Satiety Hormones (FRESH) study: A randomized cross-over clinical trial.
Rationale and design of the frequency of eating and Satiety Hormones (FRESH) study: A randomized cross-over clinical trial.
复制标题
进食频率和饱腹感激素 (FRESH) 研究的基本原理和设计：一项随机交叉临床试验。
DOI：
10.1016/j.conctc.2019.100334
复制
发表时间：
2019
影响因子：
1.5
通讯作者：
Perrigue,MartineM
中科院分区：
文献类型：
--
作者：
Neuhouser,MarianL;Clowry,Catherine;Beatty,SarahJ;Wang,Ching-Yun;Drewnowski,Adam;Perrigue,MartineM
研究背景进食频率和饱腹感激素(Fresh)研究的目标是了解进食频率(EF)与食欲和疾病风险的生物标志物之间的关系。这份报告给出了研究的理论基础和设计。方法新鲜研究是在n = 50超重和肥胖，但其他健康，18-50岁的男性和女性成年人。协议包括四次面对面的诊所访问，进行礼仪指导、抽血、人体测量和膳食测试；所有其他活动都在家里进行。参与者按随机顺序完成了两个为期21天的阶段，并在阶段之间进行了两周的冲刷。高EF期(6次/天)和低EF期(3次/天)。每个阶段都为每个用餐场合规定了一天中的时间。在整个研究过程中，参与者使用研究提供的个性化、结构化的膳食计划来准备他们自己的食物，以确保在两个研究阶段卡路里、大量营养素和微量营养素是相同的。在每个阶段的前后采集空腹血液，以测试对生物标志物的干预效果。在每个阶段结束时，参与者还完成了研究诊所准备的食物的扩展食欲测试。结果参与者是通过平面、广播和数字广告招募的。60名参与者同意登记；10名因工作或学校安排冲突而辍学，50名(目标样本量)完成了研究。通过完成每日在线膳食计划检查表来评估依从性。结论这项新的研究将提供数据，根据对健康和疾病风险的生物标记物的干预效果，在恒定的能量和营养摄入的背景下，每日EF较高或较低是否有害或有益。
BackgroundThe goal of the Frequency of Eating and Satiety Hormones (FRESH) Study is to understand the relationship between eating frequency (EF) and biomarkers of appetite and disease risk. This report gives the study rationale and design.MethodsThe FRESH study was conducted in n = 50 overweight and obese, but otherwise healthy, male and female adults aged 18–50 years. The protocol included four in-person clinic visits for protocol instruction, blood draws, anthropometry, and meal testing; all other activities were done at home. Participants completed two 21-day phases in random order with a two-week washout between phases. One phase was high EF (6 eating occasions/day) and the other was low EF (3 eating occasions/day). Each phase specified time of day for each eating occasion. Participants prepared their own meals throughout the study using study-provided individualized, structured meal plans ensuring that calories, macronutrients and micronutrients were identical during both study phases. Fasting blood was collected before and after each phase to test intervention effects on the biomarkers. At the end of each phase participants also completed extended appetite testing with meals prepared by the study clinic.ResultsParticipants were recruited using print, radio, and digital ads. 60 participants consented to enroll; 10 dropped out due to work or school scheduling conflicts and 50 (target sample size) completed the study. Compliance was assessed by completion of daily on-line meal plan checklists.ConclusionsThe FRESH study will provide data on whether higher vs. lower daily EF in the context of constant energy and nutrient intake may be harmful or beneficial based on intervention effects on biomarkers of health and disease risk.