Clinical trial NCT04808128: The Effect of Energy Drinks Consumption on Acute Physiological and Psychological Responses of Israeli Arab Adolescents
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Energy Drinks
Keywords: Energy drinks (EDs)
Blood pressure (BP)
Glucose tolerance
Metabolite profiles
Mood
Anxiety
Lead sponsor: Tel Hai College
Sponsor class: OTHER
Collaborators: name: Saint Vincent De Paul - French Hospital - Nazareth
First posted: 2021-03-22
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood sugar change
timeFrame: First measurement at baseline, before consuming the meal, and four times during the intervention - 15, 30, 60 and 120 minutes after consuming the meal
measure: Anxiety status
timeFrame: During the intervention, 60 minutes after consuming the meal.
measure: Mood change
timeFrame: First measurement at baseline, before consuming the meal, and another measurement during the intervention, 60 minutes after consuming the meal.
measure: Insulin levels status
timeFrame: During the intervention, between 30-45 minutes after consuming the meal.
measure: SCFA levels status
timeFrame: During the intervention, between 30-45 minutes after consuming the meal.
measure: HR change
timeFrame: 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 outcomes:
measure: BP change
timeFrame: First measurement at baseline, before consuming the meal, and four times during the intervention - 15, 30, 60 and 120 minutes after consuming the meal
measure: Life habits status
timeFrame: During intervention, 60 minutes after consuming the meal.
measure: Energy drinks consumption status
timeFrame: During intervention, 60 minutes after consuming the meal.
measure: Caffeine consumption frequency
timeFrame: During intervention, 60 minutes after consuming the meal.
Other outcomes:
Locations:
city: Nazareth
country: Israel
facility: Saint Vincent De Paul hospital
Study officials:
affiliation: Nutritional sciences Department Tel-Hai College
name: Lili Nimri, Dr.
role: PRINCIPAL_INVESTIGATOR
References: