Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability (Biogreen)
To achieve optimal health and to reduce the risk of age-related chronic diseases through an easily achievable dietary modification not achievable by the limited mixture of antioxidant supplements in older subjects, the investigators will focus their attention on the biological functions of bioactive plant food (Angelica keiskei and/or Glycine max) and its effect on genomic stability using noble assays.
The investigators propose to study the ability of bioactive plant-based food (Nutrition bar made from Angelica keiskei and/or Glycine max) to 1) exert biological functions: increase total antioxidant performance, decrease oxidative stress in vivo, and 2) affect genomic stability: decrease DNA damage and modify DNA methylation. The investigators hypothesize that bioactive plant food (green leafy vegetable power, and/or black bean power) will exert biological functions and affect genomic stability far more efficiently than the limited mixture of purified antioxidant supplements in the vulnerable population, older subjects (> 50 years, men and postmenopausal women) with and without metabolic syndrome.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02111
- Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University
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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: healthy control group (n=20)
- Age: over 50 years old
- Female subjects must be post-menopausal
- BMI: 18.5 - 30, waist/hip ratio < 0.9 for men, < 0.85 for women
- TG<150 mg/dL (1.7 mmol/L) and no medication for TG
- Total cholesterol < 200 mg /dL (5.18 mmol/L) and no medication for cholesterol
- Blood pressure: SBP < 130 mmHg and DBP < 85 mmHg and no hypertensive medication
- Plasma glucose: fasting blood glucose < 100 mg/dL (5.6 mmol/L) and no diabetes medication
Inclusion Criteria: Metabolic syndrome (n=40)
- Age: over 50 years old
- BMI: > 30 or waist/hip ratio > 0.9 for men, > 0.85 for women
Plus any two of the following four factors:
- TG: 150-400 mg/dL (1.7 - 4.52 mmol/L) and/or medication for TG
- HDL cholesterol: <40 mg /dL (1.03 mmol/L) for men, <50 mg/dL (1.29 mmol/L) for women and/or medication for cholesterol
- Blood pressure: SBP, 130-160 mmHg and/or DBP 85-95 mmHg and/or antihypertensive medication
- Plasma glucose: fasting blood glucose 100-125 mg/dL (5.55- 6.94 mmol/L) and no diabetes medication
Exclusion Criteria:
- Study participants will be screened for normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption.
- Subjects with a history of kidney stones, active small bowel disease or resection, atrophic gastritis, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders will be excluded from the study.
- Exogenous hormone users will be excluded from the study.
- Moreover, subjects will be non-smokers and will not have taken vitamin or carotenoid supplements for at least 6 weeks prior to the study and throughout the study for both healthy subjects and subjects with metabolic syndrome.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 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 |
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安慰剂比较:placebo
Rice powder based nutrition bar
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Nutrition bars made from Angelica keiskei (5g), glycine max (5g), Angelica keiskei (2.5g) + Glycine max (2.5g) or rice powder (12g) will be supplemented twice/day for 4 wks.
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实验性的:Angelica keiskei
Angelica keiskei (green leafy vegetable) based nutrition bar
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Nutrition bars made from Angelica keiskei (5g), glycine max (5g), Angelica keiskei (2.5g) + Glycine max (2.5g) or rice powder (12g) will be supplemented twice/day for 4 wks.
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实验性的:Glycine max
Glycine max (black soybeans) based nutrition bar
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Nutrition bars made from Angelica keiskei (5g), glycine max (5g), Angelica keiskei (2.5g) + Glycine max (2.5g) or rice powder (12g) will be supplemented twice/day for 4 wks.
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实验性的:Angelica keiskei + Glycine max
Angelica keiskei (green leafy vegetable) and glycine max (black soybeans) based nutrition bar
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Nutrition bars made from Angelica keiskei (5g), glycine max (5g), Angelica keiskei (2.5g) + Glycine max (2.5g) or rice powder (12g) will be supplemented twice/day for 4 wks.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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plasma total antioxidant performance, DNA damage and DNA methylation
大体时间:baseline, 2 & 4 wks after supplementation
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baseline, 2 & 4 wks after supplementation
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次要结果测量
结果测量 |
大体时间 |
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hydrophilic and lipophilic antioxidant nutrients (carotenoids, tocopherols, ascorbic acid and uric acid)
大体时间:Baseline, 2 & 4 wks after supplementation
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Baseline, 2 & 4 wks after supplementation
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
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
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代谢综合征的临床试验
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