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

项目总结 肥胖症的流行助长了心脏代谢性疾病的大幅增加。越来越多的证据 这表明心脏代谢性疾病与肠道微生物区系的改变有关。观测性和 干预数据同意，有提示性的证据表明，地中海式的健康饮食可能是 与肠道微生物区系的有益变化有关。然而，文学尚未达成共识。更多 需要研究肠道微生物区系如何调节饮食对心脏代谢风险的影响 以社区为基础的饮食干预措施。重要的是，奖学金要在社区内进行- 基于饮食干预，以便测量的饮食变化是完整的饮食(而不是 具体的饮食成分)，因此参与者更可持续。为了解决这些差距，这笔赠款 对地中海饮食模式的随机解释性试验提出多样性补充方案 初级保健实践的减肥干预(R33HL142680)。母公司的首要目的 R33是为了测试强调健康饮食模式的减肥干预是否能产生效果 长期的体重减轻和改善的心血管疾病风险比通常的护理(WWTM-以前的慧俪轻体)。 这项研究将通过评估4个月、12个月和24个月的结果来测试中南干预的影响 360名患者的样本。还将在每个时间点收集粪便样本。目前的提案 利用父母R33招募的患者来调查中南干预对 随着时间的推移肠道微生物区系。为此，我们将使用Baseline完成粪便DNA的16S rRNA测序 以及为期4个月的干预样本。我们的目标是(1)评估横截面之间的关联 参与者干预前的基线饮食和微生物区系组成，以及(2)测试肠道的变化 从基线到4个月的干预随访期间的微生物群落组成。对于每项研究 参与者，微生物分析措施包括：(1)α-多样性、(2)β-多样性和(3)丰度 指不同的分类(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).