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

Energy Drinks Clinical Trial

— EDE  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04808128
• Other study ID #: TelHaiC-EDE
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: October 2022

Study information

• Verified date: March 2021
• Source: Tel Hai College
• Contact: Lili Nimri, Dr.
• Phone: 972-547648223
• Email: lili.nimri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2022
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Energy Drinks

Intervention

Other:
• Drink A + SC
Consumption of energy drink that contains 80mg caffeine and 27g carbohydrates per 250ml together with simple carbohydrates.
• Drink B + SC
Consumption of soft drink, non-caffeine drink that contains 27g carbohydrates per 250ml together with simple carbohydrates.
• Drink C + SC
Consumption of soda water, non-caffeine and non-carbohydrate drink together with simple carbohydrates.
• Drink A + CC
Consumption of energy drink that contains 80mg caffeine and 27g carbohydrates per 250ml together with complex carbohydrates.
• Drink B + CC
Consumption of soft drink, non-caffeine drink that contains 27g carbohydrates per 250ml together with complex carbohydrates.
• Drink C + CC
Consumption of soda water, non-caffeine and non-carbohydrate drink together with complex carbohydrates.

Locations

Country	Name	City	State
Israel	Saint Vincent De Paul hospital	Nazareth

Sponsors (2)

Lead Sponsor	Collaborator
Tel Hai College	Saint Vincent De Paul - French Hospital - Nazareth

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.