The Effects of Mango on Gut Health Markers
The Effects of Fresh Mango Consumption on Gut Permeability Markers and Short Chain Fatty Acid Production in Individuals With Prediabetes
This is an ancillary study of NCT06159543, which was a clinical trial that examined the effect of a 12-week 1.5 cups daily mango crossover intervention on cardiometabolic outcomes in individuals with prediabetes, male and female, and 40-60 years of age. The goal of this ancillary study is to test the effect of the mango intervention on gut health markers in individuals with prediabetes. The main questions it aims to answer are:
- What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of gut permeability as measured by lipopolysaccharide-binding protein (LBP) and soluble CD14 (sCD14)?
- What is the effect of 1.5 cups per day of fresh mango over 12 weeks on microbiome modulation as estimated by short chain fatty acids (SCFAs)?
Secondarily:
- Is LBP a mediator of the relationship between systemic inflammation [as determined by C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1)] and SCFAs?
- Is LBP a mediator of the relationship between insulin resistance [as determined by HOMA-IR] and SCFAs?
- Is sCD14 a mediator of the relationship between systemic inflammation [as determined by C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1)] and SCFAs?
- Is sCD14 a mediator of the relationship between insulin resistance [as determined by HOMA-IR] and SCFAs?
Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in LBP, sCD14, and SCFAs.
As noted, this is an ancillary study of NCT06159543. Fasting blood was collected at baseline, and at the end of each phase of NCT06159543. This blood will be used to analyze LBP, sCD14 and SCFAs. Fasting blood and insulin were analyzed in NCT06159543, and will used to calculate HOMA-IR in the ancillary study. C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1) will be analyzed NCT06159543.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Amandeep Wright, MPH
- 电话号码:47169 (909) 558-4300
- 邮箱:amawright@llu.edu
研究联系人备份
- 姓名:Celine Heskey, DrPH
- 电话号码:47181 (909) 558-1000
- 邮箱:cheskey@llu.edu
学习地点
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California
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Loma Linda、California、美国、92350
- Nutrition Research Center, School of Public Health, Loma Linda University
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Participated in NCT06159543
Exclusion Criteria:
- Did not participate in NCT06159543
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Mango added to habitual diet
In NCT06159543 participants were asked to consume 1.5 cups of mango per day for 12 weeks as part of their habitual diet.
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每天 1.5 杯芒果,持续 12 周
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无干预:Habitual diet without mango
In NCT06159543 participants were asked to refrain consuming mangoes for 12 weeks while continuing their habitual diet.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Lipopolysaccharide-binding protein (LBP)
大体时间:From baseline to the end of 8 months
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Lipopolysaccharide-binding protein (LBP) will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.
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From baseline to the end of 8 months
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sCD14
大体时间:From baseline to the end of 8 months
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sCD14 will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.
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From baseline to the end of 8 months
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Short Chain Fatty Acids (SCFAs)
大体时间:From baseline to the end of 8 months
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Short Chain Fatty Acids (SCFAs) will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.
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From baseline to the end of 8 months
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合作者和调查者
调查人员
- 首席研究员:Celine Heskey, DrPH、Loma Linda University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 5260012
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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