College of Agriculture & Life Sciences, Department of Nutritional Sciences, University of Arizona, Tucson, AZ, USA.
Mel & Enid Zuckerman College of Public Health, Department of Health Promotion Sciences, University of Arizona, Tucson, AZ, USA.
Nutr J. 2018 Feb 9;17(1):16. doi: 10.1186/s12937-018-0329-y.
In the U.S., Hispanics have among the highest rates of overweight and obesity when compared to other racial/ethnic groups placing them at a greater risk for obesity-related disease. Identifying intervention strategies to reduce caloric intake and/or improve cardiometabolic health in Hispanics is critical to reducing morbidity and mortality among this large and growing population. Evidence exists to support diet-specific behavioral interventions, including beverage modifications, in reducing obesity-related health risks. However, the acceptability and feasibility of a beverage intervention in obese Hispanic adults has not been robustly evaluated.
The objective of this pilot study is to assess the feasibility and acceptability of a randomized, controlled beverage intervention in 50 obese Hispanic adults ages 18-64 over 8-weeks. Eligible participants were obese (30-50.0 kg/m), between the ages 18-64, self-identified as Hispanic, and were able to speak, read, and write in either English and/or Spanish. Study recruitment was completed August 2017. Upon the completion of baseline assessments, participants will be randomized to either Mediterranean lemonade, Green Tea, or flavored water control. After completing a 2-week washout period, participants will be asked to consume 32 oz. per day of study beverage for 6-weeks while avoiding all other sources of tea, lemonade, citrus, juice, and other sweetened beverages; water is permissible. Primary outcomes will be recruitment, retention, and acceptability of the intervention strategies. Our study will also evaluate participant-reported tolerance and as an exploratory aim, assess safety/toxicity-related to renal and/or liver function. Fasting blood samples will be collected at baseline and 8-weeks to assess the primary efficacy outcomes: total cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL). Secondary outcomes include fasting glucose, hemoglobin A1c (HbA1c), and high-sensitivity C-reactive protein (hs-CRP).
This pilot study will provide important feasibility, safety, and early efficacy data necessary to design a larger, adequately-powered randomized controlled trial.
NCT02911753 ( ClinicalTrials.gov ). Registered September 19, 2016. Last updated November 1, 2017.
在美国，与其他种族/族裔群体相比，西班牙裔人群的超重和肥胖率最高，这使他们面临更大的肥胖相关疾病风险。确定减少西班牙裔人群卡路里摄入量和/或改善心脏代谢健康的干预策略对于降低这个庞大且不断增长的人群的发病率和死亡率至关重要。有证据表明，专门针对饮食的行为干预措施，包括饮料调整，可降低与肥胖相关的健康风险。然而，肥胖的西班牙裔成年人对饮料干预措施的接受度和可行性尚未得到充分评估。
本研究旨在评估 50 名年龄在 18-64 岁的肥胖西班牙裔成年人接受为期 8 周的随机对照饮料干预的可行性和可接受性。合格参与者为肥胖（体重指数 30-50.0kg/m）、年龄在 18-64 岁之间、自我认同为西班牙裔、能够用英语和/或西班牙语进行听说读写。研究招募于 2017 年 8 月完成。在完成基线评估后，参与者将被随机分配到地中海柠檬水、绿茶或调味水对照组。完成 2 周洗脱期后，参与者将被要求在 6 周内每天饮用 32 盎司研究饮料，同时避免饮用所有其他茶、柠檬水、柑橘类水果、果汁和其他甜饮料；允许饮水。主要结局为干预策略的招募、保留和可接受性。我们的研究还将评估参与者报告的耐受性，并作为探索性目标，评估与肾功能和/或肝功能相关的安全性/毒性。在基线和 8 周时采集空腹血样，以评估主要疗效结局：总胆固醇、高密度脂蛋白（HDL）和低密度脂蛋白（LDL）。次要结局包括空腹血糖、糖化血红蛋白（HbA1c）和高敏 C 反应蛋白（hs-CRP）。
本研究将提供重要的可行性、安全性和早期疗效数据，为设计更大、更有力的随机对照试验提供必要依据。
NCT02911753（ClinicalTrials.gov）。注册日期：2016 年 9 月 19 日。最后更新日期：2017 年 11 月 1 日。
