Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices

项目摘要 肥胖症的流行助长了心脏代谢疾病的大幅增加。越来越多的证据 表明心脏代谢疾病与肠道菌群的改变有关。观测和 干预数据一致认为，有暗示性证据表明，有益心脏健康的地中海式饮食可能 与肠道微生物群的有益变化有关。然而，文献尚未达成共识。更 需要研究肠道微生物群如何介导饮食对心脏代谢风险的影响 在以社区为基础的饮食干预中。重要的是，奖学金发生在社区- 基于饮食干预，以便测量的饮食变化是整个饮食（而不是 具体饮食成分），因此对参与者来说更可持续。为了弥补这些差距， 建议对地中海饮食模式的随机试验进行多样性补充 初级保健实践的体重减轻干预（R33 HL 142680）。家长的首要目的 R33是为了测试强调健康饮食模式（Med-South）的减肥干预是否能产生 长期减肥和改善心血管疾病的风险概况超过常规护理（WWTM-以前的体重观察者）。 这项研究将通过评估4个月、12个月和24个月的结果来测试地中海-南部干预的影响。 360名患者的样本。还将在每个时间点采集粪便样本。现时的建议 利用在父R33招募的患者调查Med-South干预对 肠道菌群的变化为此，我们将使用基线技术完成粪便DNA的16 S rRNA测序， 和4个月干预样本。我们的目标是（1）评估 参与者的基线干预前饮食和微生物群组成，以及（2）测试肠道的变化 从基线到四个月的干预随访的微生物群落组成。对于每项研究 参与者，用于分析的微生物措施包括：（1）α多样性，（2）β多样性和（3）丰度 不同的分类群（属）。

PROJECT SUMMARY The obesity epidemic has fueled major increases in cardiometabolic diseases. A growing body of evidence suggests that cardiometabolic diseases are associated with an altered gut microbiota. Observational and intervention data agree that there is suggestive evidence that a heart-healthy Mediterranean-style diet may be associated with beneficial changes in gut microbiota. However, the literature has yet to reach consensus. More research needs to be done on how the gut microbiota may mediate dietary effects on cardiometabolic risk within community-based dietary interventions. It is important that scholarship take place within community- based dietary interventions so that the dietary changes being measured are of whole diets (rather than a specific dietary component) and thus are more sustainable by participants. To address these gaps, this grant proposes a diversity supplement to the Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices (R33HL142680). The overarching purpose of the parent R33 is to test whether a weight loss intervention emphasizing a healthful eating pattern (Med-South) can yield long-term weight loss and improved CVD risk profiles over usual care (WWTM—formerly Weight Watchers). The study will test the impact of the Med-South intervention by assessing outcomes at 4, 12, and 24 months in a sample of 360 patients. Fecal samples will also be collected at each timepoint. The current proposal leverages the patients recruited in the parent R33 to investigate the impacts of the Med-South intervention on the gut microbiota over time. To do this, we will complete 16S rRNA sequencing on stool DNA using baseline and 4-month intervention samples. Our goals are to (1) assess cross-sectional association between participants' baseline pre-intervention diet and microbiota composition, and (2) test the changes in the gut microbial community composition from baseline through four months of intervention follow-up. For each study participant, microbial measures for analysis include: (1) alpha-diversity, (2) beta-diversity, and (3) abundances of distinct taxa (genera).