Nutritional Intervention to Reduce Alcohol Consumption
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Modified ketogenic diet (KD)
研究概览
简要总结
To test whether the implementation of a modified ketogenic diet (KD) is efficient in reducing outcome measures in relation to alcohol consumption in patients with alcohol use disorder (AUD).
详细描述
This pilot study aims at testing randomization and feasibility of implementing a modified KD in patients with AUD undergoing standard alcohol withdrawal treatment. For this purpose, a a standardized nutritional intervention consisting of interprofessional consultations by clinical dieticians and medical professionals will be implemented. Patients in the control group will be randomized in an AUD as usual treatment with an additional optional nutritional consultation. After dismission of inpatient care, the participants will be followed up for adherence to the modified KD in the outpatient clinic for 5 weeks.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AUD diagnosis according to Diagnostic and Statistical Manual (DSM)-5
- •BMI > 22 (because of potential modified KD-side effect of weight loss)
- •Able to give informed consent as documented by signature
- •Last alcohol drink intake within 72 hours before treatment initiation
排除标准
- •Pregnant or lactating women,
- •Inability or contraindications to undergo the investigated intervention (BMI<18)
- •Clinically significant concomitant diseases impairing reasonable decision making (e.g. psychosis, dementia)
- •Inability to follow the procedures of the study, e.g. due to language problems, Previous enrolment in a clinical trial
- •Patients undergoing opioid maintenance treatment
- •Patients taking medications for drinking relapse prevention
- •Patients with a blood hemoglobin A1C (HbA1C) > 7%
研究组 & 干预措施
Modified ketogenic diet
The modified Atkins KD is defined as <20g carbohydrate per day with freely allowed protein consumption. Recommended protein and fat intake will be calculated for each participant based on their energy needs.
干预措施: Modified ketogenic diet (Dietary Supplement)
Nutritional consultation
Patients in the control group will have the option to receive an individual consultation by a clinical dietician during the inpatient setting, addressing the specific nutritional needs of people with AUD and providing the knowledge of an adequate and balanced diet.
干预措施: Individual nutritional consultation (Other)
结局指标
主要结局
Modified ketogenic diet (KD)
时间窗: 8 weeks
Patients'adherence to the modified KD during the study by percentage of prospective food intake recording of meal plans and measurement of the state ketosis by capillary blood readings of ketones.
次要结局
- Drinking outcome(8 weeks)
- Nutritional outcome(8 weeks)