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

Tel Hai College

Status: Unknown

Conditions: Energy Drinks

Treatments: Other: Drink B + CC; Other: Drink A + CC; Other: Drink A + SC; Other: Drink C + SC; Other: Drink C + CC; Other: Drink B + SC

Study type: Interventional

Funder types: Other

Identifiers

NCT04808128

TelHaiC-EDE

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 15 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 6 patient groups

Drink A + SC

Experimental group

Description:

In t0 the group will receive 250 ml XL energy drink + 20 gr sucrose.

Treatment:

Other: Drink A + SC

Drink B + SC

Active Comparator group

Description:

In t0 the group will receive 250 ml Fanta soft drink + 20 gr sucrose.

Treatment:

Other: Drink B + SC

Drink C + SC

Active Comparator group

Description:

In t0 the group will receive 250 ml soda water + 47 gr sucrose.

Treatment:

Other: Drink C + SC

Drink A + CC

Experimental group

Description:

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.

Treatment:

Other: Drink A + CC

Drink B + CC

Active Comparator group

Description:

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.

Treatment:

Other: Drink B + CC

Drink C + CC

Active Comparator group

Description:

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.

Treatment:

Other: Drink C + CC