NCT01597076已完成1 期
Effect of an Iridoid Enriched Beverage on Skin Autofluorescence
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- skin autofluorescence (akin advanced glycation end products)
研究概览
简要总结
The objectives of this clinical trial are to evaluate the effectiveness of an iridoid enriched beverage containing noni and cornelian juices and olive leaf extract on advanced glycation end product levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females age 25 to 60 years.
- •Overweight or obese, defined as BMI 23.0 to 39.9 kg/m
- •Impaired fasting glucose, defined as fasting blood glucose 100 to 125 mg/dl.
- •Prehypertension or Grade 1 hypertension, defined as systolic blood pressure 120-159 mm Hg AND diastolic BP 80-99 mm Hg.
- •Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
- •Consent to the study and willing to comply with study procedures.
排除标准
- •Prescription medication use for hypertension, high cholesterol, diabetes, heart disease, cancer, liver disease, or AIDS/HIV
- •Intake of foods and/or dietary supplements that may confound study outcomes including any use of a noni-based dietary supplement in the last month.
- •Regular use (> 3 times per week over the past month) of any dietary supplement that contains "super fruits" or high antioxidant concentrations.
- •Regular use (> 3 times per week over the past month) of any dietary supplement intended to alter or regulate blood glucose levels.
- •Any medical conditions or diseases that may affect subject safety or confound study results (in the opinion of the investigator).
- •Pregnant or lactating female.
- •History of alcohol, drug, or medication abuse.
- •Current heavy smokers (1 or more packs/day).
- •Allergies to any ingredient in the investigational products.
- •Participation in another study with any investigational product.
结局指标
主要结局
skin autofluorescence (akin advanced glycation end products)
时间窗: Baseline and week 8
skin autofluorescence with AGE reader
次要结局
未报告次要终点
研究者
研究点 (2)
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