The Effect of Energy Drinks Consumption on Acute Physiological and Psychological Responses of Israeli Arab Adolescents: In Search for a Possible Microbiota-derived Metabolite-dependent Mechanism.
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Anxiety status
研究概览
简要总结
Quasi-experiment and Cross-sectional study, six-arm design protocol will be carried out. The study will be conducted under the Declaration of Helsinki.
The current study will assess the effects of EDs consumption on the physiological and psychological responses of Israeli Arab adolescents. These effects will also be examined in association with the adolescent's plasma metabolite profiles.
The study has five specific aims: (1) to assess the effects of ED consumption with or without a meal, on Israeli Arab adolescents glucose levels by using mixed meal tolerance test (MMTT) (2) to assess the effect of ED consumption with or without a meal on their blood pressure (3) to evaluate the association between ED consumption per day by the Israeli Arab adolescents and their nutritional status and habits (4) to examine for possible associations between Israeli Arab adolescents psychological status (i.e. mood and anxiety) and ED consumption per day (5) to examine for possible associations between ED and caffeine consumption and plasma metabolite profiles and, the subject's psychological status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Israeli Arab adolescents
- •aged 14.5-17.5 years
排除标准
- •hypoglycemic episodes
- •coronary heart disease, cardiac arrhythmia, secondary hypertension, structural heart lesions
- •hepatic or renal disorders
- •autonomic neuropathy
- •obstructive sleep apnea
- •migraines
- •caffeine intolerance
- •eating disorders or other mental disorders or those with prescribed psychiatric medications
结局指标
主要结局
Anxiety status
时间窗: During the intervention, 60 minutes after consuming the meal.
Anxiety status will be measured one time during the intervention - 60 minutes after consuming the meal, with the SCARED-R questionnaire (Muris et al., 1999) in Arabic. SCARED-R is a self-report questionnaire which measures anxiety status in the last 3 months. Contains 41 statements (such as "I am nervous") in Likert scale of 0 ("Not True or Hardly Ever True") to 2 ("Very True or Often True"). A total score of ≥ 25 may indicate the presence of an Anxiety Disorder.
SCFA levels status
时间窗: During the intervention, between 30-45 minutes after consuming the meal.
SCFA levels status will be measured based on blood samples that will be taken from subjects during the intervention, 30-45 minutes after consuming the meal. Analysis will take place after the data collection stage.
Insulin levels status
时间窗: During the intervention, between 30-45 minutes after consuming the meal.
Insulin levels status will be measured based on blood samples that will be taken from subjects during the intervention, 30-45 minutes after consuming the meal. Analysis will take place after the data collection stage.
HR change
时间窗: First measurement at baseline, before consuming the meal, and four times during the intervention - 15, 30, 60 and 120 minutes after consuming the meal
Changes in heart rate (BPM) will be measured five times - First at baseline (before consuming the meal) and four times during the intervention - 15, 30, 60 and 120 minutes after consuming the meal.
Blood sugar change
时间窗: First measurement at baseline, before consuming the meal, and four times during the intervention - 15, 30, 60 and 120 minutes after consuming the meal
Change in blood sugar levels (mg/dL) will be measured with the mixed meal tolerance test (MMTT) five times - one time at baseline (before consuming the meal) and four times during the intervention (15, 30, 60 and 120 minutes after consuming the meal).
Mood change
时间窗: First measurement at baseline, before consuming the meal, and another measurement during the intervention, 60 minutes after consuming the meal.
Mood change will be measured two times - one time at baseline (before consuming the meal) and another time during the intervention - 60 minutes after consuming the meal. Mood will be measured with the UMACL questionnaire (Matthews et al., 1990) in Arabic. UMACL is a self-report questionnaire which measures the current mood of the subject. Contains 29 statements (such as "I am happy"), in Likert scale of 1 ("absolutely") to 4 ("not at all"). The higher the score, the better the current mood is.
次要结局
- Energy drinks consumption status(During intervention, 60 minutes after consuming the meal.)
- BP change(First measurement at baseline, before consuming the meal, and four times during the intervention - 15, 30, 60 and 120 minutes after consuming the meal)
- Life habits status(During intervention, 60 minutes after consuming the meal.)
- Caffeine consumption frequency(During intervention, 60 minutes after consuming the meal.)