Metabolic Imprints of Alcoholic Beverages
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- DHEAS
研究概览
简要总结
Metabolic imprints of five different types of alcohol will be investigated in two study groups.
The study will be an assessor-blinded, parallel dietary trial (crossover design).
The project aims to identify the chemical nature and kinetics of metabolite changes related to alcohol, hops, grapes and other beverage constituents as well as the brewing processes.
详细描述
Metabolic imprints of five different types of alcohol will be investigated in two study groups of 15 participants in each with equal distribution of gender, occasional (0-2 u/week) and habitual drinkers (>2 u/week), respectively.
The intervention is divided into two periods: abstaining and drinking period. Occasional drinkers begin the abstaining intervention and habitual drinkers begin the drinking intervention, and cross-over after 3 weeks.
In the drinking period women consume 1 unit/day and men 2 units/day.
Study participants will consume five different types of alcohol; beer, cider, white wine, red wine and spirits. The sequence of alcohol consumption in the drinking period is randomized by 'random number allocation'.
Study participants are asked to collect 24h urine samples three days in beginning of each intervention and one day in the end of last intervention. The remaining days of the trial they are asked to make a urine spot test each morning at home. Beside urine samples, they are to give blood samples on each trial day and at screening (6 times). Overnight-fasting blood samples are drawn at day 0, 1 and 21, 22 and 42 of the six week intervention and one at screening before intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Intake of alcoholic drinks or abstaining cannot be masked to participants or care providers (delivering the alcoholic beverages). The outcomes included biomarkers of alcohol intake so in practice the investigator and outcomes assessor could not be blinded either.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 years of age
- •No intolerance of alcohol
- •Experience with alcohol
- •Able to use smartphone or tablet
排除标准
- •Serious chronic health conditions or psychiatric diseases
- •Chronic intake of medicine (beside birth control and SSRI)
- •Alcohol and/or drug abuse assessed AUDIT score >4 (AUDIT = Alcohol Use Disorders Identification Test).
- •Blood samples/donations during trial and 3 months prior
- •Liver dysfunction
- •High risk of breast cancer assessed by BCRAT score (BCRAT = The Breast Cancer Risk Assessment Tool)
- •Pregnancy or lactating
研究组 & 干预措施
Drinking
Occasional drinkers assigned to start with a 3week drinking period (women 1 u/day - men 2 u/day)
Followed by crossover without washout to 3 week abstaining period
干预措施: Drinking (Dietary Supplement)
Drinking
Occasional drinkers assigned to start with a 3week drinking period (women 1 u/day - men 2 u/day)
Followed by crossover without washout to 3 week abstaining period
干预措施: Abstaining (Other)
Abstaining
Habitual drinkers assigned to start 2 weeks of abstaining from alcohol
Followed by crossover without washout to 3 weeks drinking (women 1 u/day - men 2 u/day)
干预措施: Drinking (Dietary Supplement)
Abstaining
Habitual drinkers assigned to start 2 weeks of abstaining from alcohol
Followed by crossover without washout to 3 weeks drinking (women 1 u/day - men 2 u/day)
干预措施: Abstaining (Other)
结局指标
主要结局
DHEAS
时间窗: 3 weeks
Changes in dehydroepiandrosterone sulphate (DHEAS) and related (steroid) hormones and metabolites
次要结局
- Metabolites from outcomes 1-4 measured in a hair sample(3 weeks (1 day))
- Blood lipids(3 weeks)
- Markers of alcohol intake(3 weeks)
- Human microbial co-metabolites(3 weeks)
- Markers of intake of raw materials from the beverage productions(1 day)
- Metabolites from outcomes 1-4 measured in dry urine spots(1 day)
- Metabolites from outcomes 1-4 measured in dry blood samples(1 day)
- Psychosocial well-being(3 weeks)
- Blood pressure(1d - 3 weeks)
- Fibrinogen(3 weeks)
- Physical activity monitoring(1d - 3weeks)
- Adiponectin(3 weeks)
研究者
Professor Lars Ove Dragsted
Professor, Head of Section
University of Copenhagen