Fulvic Acid Supplementation and Metabolic Syndrome
Evaluation of Fulvic Acid Supplementation for the Attenuation of Symptoms Associated With Metabolic Syndrome
Fulvic acid is a naturally occurring compound derived from the decomposition of organic matter in soil over long periods. Fulvic acid complexes, such as MLG-50 (MLG-50® Mineral Logic, Kalamazoo, Michigan), offer a highly concentrated, water-soluble form of fulvic acid that contains over 70 trace minerals and elements. Our preclinical studies have found that a soil derived organic mineral complex rich in fulvic acid prevented the high fat diet induced hyperglycemia, endothelial dysfunction, liver injury, endotoxemia, and gut dysbiosis induced by high-fat feeding in rats. We propose to examine the efficacy of fulvic acid (both 50 mg and 100 mg daily for 12 weeks) in the mitigation of symptoms related to metabolic syndrome.
研究概览
详细说明
Clinical trials examining the efficacy of fulvic acid on health parameters are scarce. However, shilajit, a natural substance rich in fulvic acid, was shown to reduce triglycerides, cholesterol, and increase HDL cholesterol as well as antioxidant status in healthy college students (n=30) after 45 days of supplementation (2 g daily). However, this quasi-experimental trial did not randomize participants into experimental groups, and causality cannot be evaluated. A 2018 review of the peer-reviewed literature on the therapeutic potential of fulvic acid concluded that although the available research is minimal, there was 'substantial evidence' to pursue fulvic acid research for improving biomarkers linked to chronic inflammatory diseases.
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：Carol Johnston, PhD
- 电话号码：6024963463
- 邮箱：carol.johnston@asu.edu
研究联系人备份
- 姓名：Karen Sweazea, PhD
- 电话号码：4809656025
- 邮箱：karen.sweazea@asu.edu
学习地点
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Arizona
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Phoenix、Arizona、美国、85004
- 招聘中
- PBC 850 N 5th Street
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接触：
- Carol Johnston, PhD
- 电话号码：6024962539
- 邮箱：carol.johnston@asu.edu
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接触：
- Karen Sweazea, PhD
- 电话号码：4809656025
- 邮箱：karen.sweazea@asu.edu
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- metabolic syndrome or prediabetes
Exclusion Criteria:
- pregnant or nursing
- multiple medications to treat obesity, heart disease, thyroid conditions, cancer
- smokers
- competing athletes
- vegetarians
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Fulvic acid 50
50 mg |
50 mg 100 mg |
|
实验性的：Fulvic acid 100
100 mg |
50 mg 100 mg |
|
安慰剂比较：Placebo
cornstarch |
cornstarch |
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 |
|---|---|---|
|
girth
大体时间：from enrollment to 6 week and to 12 week
|
waist circumference in cm |
from enrollment to 6 week and to 12 week
|
|
hypertension
大体时间：from enrollment to 6 week and to 12 week
|
diastolic and systolic blood pressure |
from enrollment to 6 week and to 12 week
|
|
hyperglycemia
大体时间：from enrollment to 6 week and to 12 week
|
fasting blood glucose |
from enrollment to 6 week and to 12 week
|
|
hypertriglyceridemia
大体时间：from enrollment to 6 week and to 12 week
|
fasting blood triglycerides |
from enrollment to 6 week and to 12 week
|
|
cholesterol
大体时间：from enrollment to 6 week and to 12 week
|
fasting blood HDL cholesterol |
from enrollment to 6 week and to 12 week
|
合作者和调查者
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.