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

NCT04808128 | Unknown

• 1 other identifier: TelHaiC-EDE
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Energy Drinks

Keywords

Energy drinks (EDs); Blood pressure (BP); Glucose tolerance; Metabolite profiles; Mood; Anxiety

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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.

• Energy drinks consumption status

  During intervention, 60 minutes after consuming the meal.

• Caffeine consumption frequency

  During intervention, 60 minutes after consuming the meal.

Study Arms (6)

Drink A + SC

EXPERIMENTAL

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

Other: Drink A + SC

Drink B + SC

ACTIVE COMPARATOR

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

Other: Drink B + SC

Drink C + SC

ACTIVE COMPARATOR

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

Other: Drink C + SC

Drink A + CC

EXPERIMENTAL

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

Drink B + CC

ACTIVE COMPARATOR

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

Drink C + CC

ACTIVE COMPARATOR

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

Interventions

Drink A + SC OTHER

Consumption of energy drink that contains 80mg caffeine and 27g carbohydrates per 250ml together with simple carbohydrates.

Drink A + SC

Drink B + SC OTHER

Consumption of soft drink, non-caffeine drink that contains 27g carbohydrates per 250ml together with simple carbohydrates.

Drink B + SC

Drink C + SC OTHER

Consumption of soda water, non-caffeine and non-carbohydrate drink together with simple carbohydrates.

Drink C + SC

Drink A + CC OTHER

Consumption of energy drink that contains 80mg caffeine and 27g carbohydrates per 250ml together with complex carbohydrates.

Drink A + CC

Drink B + CC OTHER

Consumption of soft drink, non-caffeine drink that contains 27g carbohydrates per 250ml together with complex carbohydrates.

Drink B + CC

Drink C + CC OTHER

Consumption of soda water, non-caffeine and non-carbohydrate drink together with complex carbohydrates.

Drink C + CC

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy
• Israeli Arab adolescents
• aged 14.5-17.5 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel Hai College: lead
• Saint Vincent De Paul - French Hospital - Nazareth: collaborator

Study Sites (1)

Saint Vincent De Paul hospital

Nazareth, 16511, Israel

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Lili Nimri, Dr.

  Nutritional sciences Department Tel-Hai College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lili Nimri, Dr.

CONTACT

972-547648223; lili.nimri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 22, 2021
• Study Start: October 2, 2020
• Primary Completion: April 1, 2021
• Study Completion: October 1, 2022
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)