NCT03561116Unknown不适用
Effects of Xanthohumol on Metabolic Syndrome Progression (XAN4Health)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Glycated hemoglobin (HbA1c)
研究概览
简要总结
A huge body of scientific evidence has suggested that xanthohumol (XAN) consumption, a polyphenol present in beer, has a positive effect on energy metabolism. This compound is known for its antioxidant, anti-inflammatory and anti-cancer properties which confer potential to be used as a food supplement. Nevertheless, XAN lipophilic properties prevent the extensive use of this molecule as a functional food compound. The company TA-XAN S.A.M. (Wiesbaden, Germany) has patented a method to overcome this solubility problem. So, the main aim of this study is to evaluate the effects of XAN consumption on metabolic syndrome progression in individuals recently diagnosed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Triple blind
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 25-65 years of age;
- •Criteria for metabolic syndrome according to the 2005 revised NCEP ATP III guidelines:
- •HDL-C < 40 mg/dL ♂ and < 50 mg/dL ♀;
- •Triglycerides ≥ 150 mg/dL;
- •Blood pressure ≥ 130/85 mmHg;
- •Fasting plasma glucose ≥ 100 mg/dL;
- •Waist circumference ≥ 102 cm ♂ and ≥ 88 cm ♀;
- •HbA1c 5.8/6.0-6.4;
- •Nonsmokers or no other tobacco use in the last 3 months;
- •Willing to stop taking regular supplements including antioxidants for 2 weeks prior to study entry through conclusion of study;
- •Willing to stop consumption of beer for 2 weeks prior to study entry through conclusion of study;
- •Must be able to provide informed consent;
- •Blood screen tests [comprehensive metabolic panel (CMP), and lipid profile] within normal limits or if outside normal limits, approved for participation at the discretion of the study physician.
排除标准
- •Have a significant acute or chronic coexisting illness, such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrine disorder, immunological disorder, metabolic disease, cancer, chemotherapy history, gluten intolerance, eating disorders, depression or any psychiatric condition, diabetes, or any condition which contraindicates entry in the study, according to the investigators' judgment;
- •Currently taking prescription drugs other than oral contraceptives (over-the-counter medications are allowed upon review and discretion of the study physician);
- •Consumption of more than the recommended alcohol guidelines (> 1 drink/day ♀ and > 2 drinks/day ♂);
- •Consumption of high levels of beer;
- •Pregnancy (as confirmed by urine pregnancy test) or planning to become pregnant before completing the study;
- •Breastfeeding;
- •Under UV therapy (e.g. psoriasis treatment), using UV tanning beds and unprotected sun exposure greater than 1 hour/day;
- •Engaging in vigorous exercise more than 6 hours/week;
- •Participation in other dietary study in the past 3 months;
- •Had surgery in the last 3 months;
- •Post-menopausal status.
研究组 & 干预措施
XAN
Experimental
XAN (1 sachet of 12 mg/day)
干预措施: XAN (Dietary Supplement)
Placebo
Placebo Comparator
Placebo (1 sachet with excipient)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Glycated hemoglobin (HbA1c)
时间窗: Change from baseline of HbA1c at 3 months
Comet assay
时间窗: Change from baseline of DNA damage at 3 months
次要结局
- LDL-cholesterol(Change from baseline of LDL-cholesterol at 3 months)
- Heart rate(Change from baseline of heart rate at 3 months)
- ApoB(Change from baseline of ApoB at 3 months)
- ApoA1(Change from baseline of ApoA1 at 3 months)
- HDL-cholesterol(Change from baseline of HDL-cholesterol at 3 months)
- Body composition(Change from baseline of body composition at 3 months)
- Blood pressure(Change from baseline of blood pressure at 3 months)
- Triglycerides(Change from baseline of triglycerides at 3 months)
- Waist circumference(Change from baseline of waist circumference at 3 months)
- Body weight(Change from baseline of body weight at 3 months)
- Total-cholesterol(Change from baseline of total-cholesterol at 3 months)
研究者
研究点 (2)
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