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

地中海饮食模式减肥干预初级保健实践的随机解释性试验

基本信息

批准号：
10631776
负责人：
THOMAS C KEYSERLING
金额：
$ 11.12万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-06-01 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10631776
关键词：
16S ribosomal RNA sequencing Address Adopted Animals Biological Body Weight decreased Cardiometabolic Disease Cardiovascular Diseases Collection Communities Complex Consensus Country DNA Data Diet Dietary Component Dietary Intervention Dietary Practices Eating Feces Funding Future Goals Grant Health Heart Home Intervention Intervention Trial Knowledge Life Linear Regressions Literature Low income Measures Mediating Mediator of activation protein Metabolism Minority Groups Non-Insulin-Dependent Diabetes Mellitus Nutrient Obesity Epidemic Outcome Parents Participant Pathway interactions Patient Recruitments Patients Pattern Personal Satisfaction Plants Primary Health Care Production Public Health Randomized Randomized Controlled Trials Reporting Research Ribosomal RNA Sampling Scholarship Secure Structure Suggestion Testing Time Volatile Fatty Acids Weight base beta diversity cardiometabolic risk cardiometabolism cardiovascular disorder risk cohort design dietary ethnic diversity follow-up good diet gut microbiota health equity improved innovation lifestyle intervention microbial microbiota multi-ethnic preference prospective racial and ethnic randomized trial response socioeconomics stool sample therapy design treatment arm treatment as usual weight loss intervention

项目摘要

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).

项目概要肥胖流行导致心脏代谢疾病大幅增加。越来越多的证据表明心脏代谢疾病与肠道微生物群的改变有关。观察和干预数据一致认为，有暗示性证据表明，有益于心脏健康的地中海式饮食可能有益于心脏健康。与肠道微生物群的有益变化有关。然而，文献尚未达成共识。更多的需要研究肠道微生物群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。奖学金在社区内进行很重要- 基于饮食干预，以便测量的饮食变化是整体饮食（而不是单一饮食）特定的饮食成分），因此对参与者来说更具可持续性。为了解决这些差距，这笔赠款提出对地中海饮食模式随机解释试验的多样性补充初级保健实践的减肥干预（R33HL142680）。父母的首要目的 R33 旨在测试强调健康饮食模式（中南）的减肥干预措施是否能够产生效果与常规护理相比，可实现长期减肥并改善 CVD 风险状况（WWTM——前身为慧俪轻体）。该研究将通过评估 4、12 和 24 个月的结果来测试地中海南部干预措施的影响。 360 名患者的样本。还将在每个时间点收集粪便样本。目前的提案利用母体 R33 中招募的患者来调查 Med-South 干预措施对随着时间的推移肠道微生物群。为此，我们将使用基线完成粪便 DNA 的 16S rRNA 测序和 4 个月的干预样本。我们的目标是（1）评估之间的横截面关联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，用于分析的微生物指标包括：(1) α 多样性，(2) β 多样性，以及 (3) 丰度不同的分类群（属）。