Prevention of Oxidative DNA Damage by Xanthohumol
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Comparison of the change in markers of DNA damage and oxidative stress during XN treatment vs. the change during placebo
研究概览
简要总结
The purpose of this research study is to learn if and in what amount a compound from hops, called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human body is constantly exposed to oxidative stress from environmental compounds (e.g. air pollution) which may cause damage to DNA. The human body can repair some DNA damage, but too much DNA damage is harmful and may lead to cancer. Research done at OSU and around the world has shown that xanthohumol can stop or slow processes that lead to cancer.
详细描述
The purpose of this research study is to learn if and in what amount a compound from hops, called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human body is constantly exposed to oxidative stress from environmental compounds (e.g. air pollution) which may cause damage to DNA. The human body can repair some DNA damage, but too much DNA damage is harmful and may lead to cancer. Research done at OSU and around the world has shown that xanthohumol can stop or slow processes that lead to cancer.
Participants will consume a non-alcoholic beverage containing xanthohumol with breakfast, lunch and dinner for 3 weeks. Then they will go through a washout period of 3 weeks. And then they will consume the same beverage without the xanthohumol compound (placebo) for another 3 weeks. Participants will be randomly assigned into groups and will vary whether they will consume the xanthohumol product during the first or second 3-week period. Xanthohumol doses will be 0, 6, 12 or 24 mg/day.
The study includes donation of blood and urine samples and one-month food frequency questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smokers or no other tobacco use in the past 3 months.
- •Willing to stop taking regular supplements including anti-oxidants for 2 weeks prior to study entry through conclusion of study.
- •Willing to stop consumption of high levels of flavonoids and xanthohumol in the normal diet (onions, teas including green/black tea and microbrew beers) for 2 weeks prior to study entry through conclusion of study.
- •Must be able to give written informed consent.
- •Blood screen tests (Comprehensive metabolic profile [CMP] and lipid profile) within normal limits.
排除标准
- •Body Mass Index (BMI) less than 18.5 (underweight) or greater than 30 (obese)
- •Have a significant acute or chronic coexisting illness such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease, cancer, history of chemotherapy, celiac disease or gluten/wheat intolerance*, diabetes, thyroid problems, or any condition which contraindicates, in the investigators judgement, entry into the study.
- •Currently taking prescription drugs except oral contraceptives.
- •Consumption of more than the recommended alcohol guidelines i.e. >2 drinks/day.
- •Consumption of high levels of flavonoids and xanthohumol in the normal diet (onions, teas including green/black tea and microbrew beers).
- •Pregnancy (as confirmed by urine pregnancy test), breastfeeding, or planning to become pregnant before completing the study.
- •Undergoing UV therapy (e.g. treatment for skin conditions such as psoriasis), using UV tanning beds, or unprotected sun exposure greater than 1 hour per day.
- •Engaging in vigorous exercise more than 6 hours per week.
- •Participation in another dietary study in the past 3 months.
- •Had surgery in the last 3 months.
- •Post-menopausal status
- •(*Note: Beverage is formulated with a barley extract. Barley contains gluten.)
研究组 & 干预措施
6 mg xanthohumol per day vs. placebo
All participants take 6 mg xanthohumol daily and placebo in a crossover design with a washout period.
干预措施: 6 mg xanthohumol per day (Drug)
6 mg xanthohumol per day vs. placebo
All participants take 6 mg xanthohumol daily and placebo in a crossover design with a washout period.
干预措施: Placebo (Drug)
12 mg xanthohumol per day vs. placebo
All participants take 12 mg xanthohumol daily and placebo in a crossover design with a washout period.
干预措施: 12 mg xanthohumol per day (Drug)
12 mg xanthohumol per day vs. placebo
All participants take 12 mg xanthohumol daily and placebo in a crossover design with a washout period.
干预措施: Placebo (Drug)
24 mg xanthohumol per day vs. placebo
All participants take 24 mg xanthohumol daily and placebo in a crossover design with a washout period.
干预措施: 24 mg xanthohumol per day (Drug)
24 mg xanthohumol per day vs. placebo
All participants take 24 mg xanthohumol daily and placebo in a crossover design with a washout period.
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of the change in markers of DNA damage and oxidative stress during XN treatment vs. the change during placebo
时间窗: Prior to first dose on day 1 to day 63.
Plasma and urine levels of 8-oxo-dG will be measured at the beginning and end of each 3-week cycle. DNA strand breaks in blood cells and plasma levels of reduced and oxidized glutathione will be measured at the beginning and end of each 3-week cycle. Between the two cycles, there will be a 3-week washout. One cycle is XN treatment, and one cycle is the placebo.
次要结局
- Comparison of the change in metabolic profile during XN treatment vs. the change during placebo(Prior to first dose on day 1 to day 63.)
研究者
Jan Frederik Stevens
Professor of Medicinal Chemistry, Department of Pharmaceutical Sciences, College of Pharmacy
Oregon State University