Comparing the Effectiveness of Transcranial Direct Stimulation (tDCS) and Probiotic Supplementation on Risky Decision-making, Impulsivity, Self-control, and Food Selection in Overweight Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Impulsive Behavior Scale Questionnaire measuring Urgency, Premeditation (lack of), Perseverance (lack of), and Sensation seeking (UPPS)
研究概览
简要总结
The aim of the current study is to investigate and compare the effectiveness of probiotic supplementation and tDCS stimulation on risky decision-making related to food choices in overweight people. Considering the relatively established communication and interaction between the gut-brain-microbiome axis, the investigators expect that transcranial direct current stimulation and probiotic supplementation can both improve decision-making (decrease risky and impulsive decisions) and increase self-control in overweight people.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI over 25
- •Higher than normal fat level
排除标准
- •Pregnancy
- •Breastfeeding
- •Smoking more than 10 cigarettes a day
- •Excessive consumption of alcohol
- •Suffering from chronic cardiovascular and kidney diseases
- •Chronic digestive diseases such as celiac disease,
- •Chronic inflammatory bowel diseases such as colitis, intestinal surgery, cancer, etc.
- •Suffering from acute and chronic diarrhea in the last one month
- •Taking antibiotics in two months before the start of the study,
- •Continuous use of prebiotic and probiotic products and drugs in one month before the start of the intervention
- •Frequent use of antibiotics during the last month before the start of the intervention
- •Taking weight loss medications and following a special slimming diet in the last 3 months before the intervention.
- •History of epilepsy and seizures, stroke,
- •Use of pacemaker
- •Presence of metal implanted in the scalp or brain,
- •Presence of skin lesions at the tDCS stimulation site, and history of head injury or brain surgery.
- •Brain disorders and long-term and chronic use of neuropsychiatric drugs.
研究组 & 干预措施
Active tDCS over the dorsolateral prefrontal cortex (DLPFC)
In this group, participants will receive active 2 milliampere (mA) tdcs over the DLPFC (anode on F3 and cathode onF4) for 20 minutes.
干预措施: tDCS (Device)
Active tDCS over the ventromedial prefrontal cortex (VMPFC)
In this group, participants will receive active 2 mA tdcs over the VMPFC (anode on Fpz and cathode on Cz) for 20 minutes.
干预措施: tDCS (Device)
Sham tDCS Stimulation
In this group, participants will receive sham tDCS which will ramp up for 30 s at the beginning of the session and then ramp down and be switched off during the 20-minute stimulation session.
干预措施: Sham tDCS (Device)
Probiotic supplementation
In this group, participants will consume 2 probiotic supplements (The synbiotics family) daily, for one month.
干预措施: Probiotic Blend Capsule (Drug)
结局指标
主要结局
Impulsive Behavior Scale Questionnaire measuring Urgency, Premeditation (lack of), Perseverance (lack of), and Sensation seeking (UPPS)
时间窗: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
This is a self-report tool that assesses five subscales (urgency, premeditation, perseverance, sensation seeking, and positive urgency) that are used to measure five distinct dimensions of impulsive behavior; each scale ranging from 4 to 16); Higher scores represent worse outcome.
Body analysis test
时间窗: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
This is a technique to determine the percentage of body mass that is fat compared to muscle. It can also indicate where the fat and muscle are carried within the body.
Eating attitudes Test (EAT-26)
时间窗: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
This tool is used to identify the presence of "eating disorder risk" based on attitudes, feelings and behaviours related to eating. The total score (between 0 and 78) provides an overall risk score, where higher scores indicating greater risk of an eating disorder.
Balloon analogue risk task (BART)
时间窗: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
BART is a computerized decision-making task that is used to assess risk-taking behavior. The BART simulates a real-world situation, involving actual risky behavior, where taking a risk up until a certain point yields a reward.
Tangney self-control questionnaire (Form 36)
时间窗: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
This is a self-report measurement to assess individual differences in traits of self-control. Scores range from 0 to 144 with higher scores representing worse outcome.
次要结局
未报告次要终点
研究者
reza kazemi
Assistant professor
University of Tehran