Pragmatic Clinical Trial to Compare the Short and Medium Term Effects of Two Recommendations Regarding Alcohol Consumption: a Pilot Study NAMETI_ALCOHOL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total cholesterol (mg/dl)
研究概览
简要总结
NAMETI-Alcohol, from the acronym for Navarra Medical Trialist Initiative, is a pilot study in which two patterns of alcohol consumption, abstention and Mediterranean alcohol-drinking pattern, and their effects on health in the short and medium term will be compared.
详细描述
Background: Alcohol is the most consumed psychoactive substance in Spain. In 2016 it was the seventh leading risk factor for death and disability-adjusted lost years worldwide, and the first one in people between 15 and 49 years old.In the scientific community there is some controversy about what would be the best approach to face this great problem. On the one hand, there is evidence to recommend that there is no safe level of alcohol. However, on the other hand, there are studies that demonstrate the protective role of a moderate alcohol consumption. In this pilot study both options will be compared.
Methods: It is intended to recruit a total of 100 participants, including two observational cohorts of abstainers and drinkers. The intervention will be carried out in drinkers willing to change their alcohol consumption, divided into 2 groups of 50 participants, the abstention group and the Mediterranean alcohol-drinking pattern group. The Mediterranean alcohol-drinking pattern includes 5 aspects: moderate alcohol consumption (maximum of 1 drinks/day for women and 2 drinks/day for men), spread consumption throughout the week, drink with meals and never with an empty stomach, prefer wine and mainly red wine, as well as completely avoid episodes of binge-drinking. The main objective will be to compare the short and medium term effects on health of both patterns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consuming more than 3 drinks a week (except for the abstention-control arm)
排除标准
- •Sever chronic disease (cancer, cardiovascular disease, chronic hepatitis and mental illness)
- •Pregnant women or breastfeeding
- •Family or personal history of addiction, alcoholism or alcohol abuse
研究组 & 干预措施
Abstention
These participants will be encouraged to totally avoid alcohol consumption.
干预措施: Abstention (Behavioral)
Mediterranean alcohol-drinking pattern
These participants will be encouraged to change their pattern of consumption to a more Mediterranean way, which includes 5 aspects: moderate alcohol consumption (maximum of 2 drinks/day for women and 4 drinks/day for men), spread consumption throughout the week, drink with meals and never with an empty stomach, prefer wine and mainly red wine, as well as completely avoid episodes of binge-drinking.
干预措施: Mediterranean alcohol-drinking pattern (Behavioral)
Control of abstainers
This group will include all participants who consume less than 3 alcohol drinks a week at the time of recruitment.
Control of drinkers
This group will include all participants who don't want to change their alcohol-drinking pattern.
结局指标
主要结局
Total cholesterol (mg/dl)
时间窗: 1year
Changes differences in total cholesterol levels
Alanine Aminotransferase (ALT) (IU/L)
时间窗: 1 year
Changes differences in ALT
Blood pressure (mm Hg)
时间窗: 1 year
Changes differences in systolic and diastolic blood pressure
HDL-Cholesterol (mg/dl)
时间窗: 1year
Changes differences in HDL-Cholesterol levels
Triglycerides (mg/dl)
时间窗: 1 year
Changes differences in triglycerides
Glucose (mg/dl)
时间窗: 1 year
Changes differences in glucose levels
Aspartate transaminase (AST) (IU/L)
时间窗: 1 year
Changes differences in AST
Gamma-glutamyltransferase (GGT) (IU/L)
时间窗: 1 year
Changes differences in GGT
c-Reactive Protein (CRP) (mg/L)
时间窗: 1 year
Changes differences in CRP
次要结局
- Mental health(1 year)
- Weight (kg)(1 year)
- Body Mass Index (BMI) (kg/m2)(1 year)
- Adherence to the intervention(1 year)
研究者
Maira Bes Rastrollo
Professor
Clinica Universidad de Navarra, Universidad de Navarra
