The Effect of Energy Drinks Consumption on Acute Physiological and Psychological Responses of Israeli Arab Adolescents

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Energy Drinks

Intervention / Treatment
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* Other: Drink A + SC
* Other: Drink B + SC
* Other: Drink C + SC
* Other: Drink A + CC
* Other: Drink B + CC
* Other: Drink C + CC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Israeli Arab adolescents aged 14.5-17.5 years Exclusion Criteria: diabetes hypoglycemic episodes coronary heart disease, cardiac arrhythmia, secondary hypertension, structural heart lesions hepatic or renal disorders autonomic neuropathy epilepsy obstructive sleep apnea migraines caffeine intolerance eating disorders or other mental disorders or those with prescribed psychiatric medications

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drink A + SC<br>In t0 the group will receive 250 ml XL energy drink + 20 gr sucrose. | Other: Drink A + SC<br>* Consumption of energy drink that contains 80mg caffeine and 27g carbohydrates per 250ml together with simple carbohydrates.<br>|
| Active Comparator: Drink B + SC<br>In t0 the group will receive 250 ml Fanta soft drink + 20 gr sucrose. | Other: Drink B + SC<br>* Consumption of soft drink, non-caffeine drink that contains 27g carbohydrates per 250ml together with simple carbohydrates.<br>|
| Active Comparator: Drink C + SC<br>In t0 the group will receive 250 ml soda water + 47 gr sucrose. | Other: Drink C + SC<br>* Consumption of soda water, non-caffeine and non-carbohydrate drink together with simple carbohydrates.<br>|
| Experimental: Drink A + CC<br>In t0 the group will receive 250 ml XL energy drink + 20gr complex carbohydrates from one slice of bread (30g) and one spoon of hummus. | Other: Drink A + CC<br>* Consumption of energy drink that contains 80mg caffeine and 27g carbohydrates per 250ml together with complex carbohydrates.<br>|
| Active Comparator: Drink B + CC<br>In t0 the group will receive 250 ml Fanta soft drink + 20gr complex carbohydrates from one slice of bread (30g) and one spoon of hummus. | Other: Drink B + CC<br>* Consumption of soft drink, non-caffeine drink that contains 27g carbohydrates per 250ml together with complex carbohydrates.<br>|
| Active Comparator: Drink C + CC<br>In t0 the group will receive 250 ml soda water + 27gr sucrose + 20gr complex carbohydrates from one slice of bread (30g) and one spoon of hummus. | Other: Drink C + CC<br>* Consumption of soda water, non-caffeine and non-carbohydrate drink together with complex carbohydrates.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood sugar change | 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). | First measurement at baseline, before consuming the meal, and four times during the intervention - 15, 30, 60 and 120 minutes after consuming the meal | 
| Anxiety status | 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. | During the intervention, 60 minutes after consuming the meal. | 
| Mood change | 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. | First measurement at baseline, before consuming the meal, and another measurement during the intervention, 60 minutes after consuming the meal. | 
| Insulin levels status | 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. | During the intervention, between 30-45 minutes after consuming the meal. | 
| SCFA levels status | 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. | During the intervention, between 30-45 minutes after consuming the meal. | 
| HR change | 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. | First measurement at baseline, before consuming the meal, and four times during the intervention - 15, 30, 60 and 120 minutes after consuming the meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BP change | Changes in systolic and diastolic blood pressure (mm Hg) will be measured 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). | 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 | Life habits status will be measured one time during the intervention, 60 minutes after consuming the meal, using the Nutritional Status Questionnaire (based on the Israeli Ministry of Health 2nd nutrition survey [MABAT], 2017) in Arabic. The questionnaire includes 8 questions (such as Are you eating breakfast?), with no cut-off score. | During intervention, 60 minutes after consuming the meal. | 
| Energy drinks consumption status | Energy drinks consumption status will be measured one time during the intervention, 60 minutes after consuming the meal, using a questionnaire by Attila & Çakir, 2011, in Arabic. The questionnaire includes 9 questions (such as Do you drink energy drinks?), with no cut-off score. | During intervention, 60 minutes after consuming the meal. | 
| Caffeine consumption frequency | Caffeine consumption frequency will be measured one time during the intervention, 60 minutes after consuming the meal, using a questionnaire from Harpaz et al., 2016 in Arabic. The questionnaire contains 2 questions (such as Please choose the products you consumed during the last week), with no cut-off score. | During intervention, 60 minutes after consuming the meal. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Energy drinks (EDs), Blood pressure (BP), Glucose tolerance, Metabolite profiles, Mood, Anxiety