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

NCT ID: NCT04808128

Last Updated: 2021-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-02

Study Completion Date

2022-10-31

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.

Detailed Description

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Conditions

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Energy Drinks

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Drink A + SC

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

Group Type EXPERIMENTAL

Drink A + SC

Intervention Type OTHER

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

Drink B + SC

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

Group Type ACTIVE_COMPARATOR

Drink B + SC

Intervention Type OTHER

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

Drink C + SC

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

Group Type ACTIVE_COMPARATOR

Drink C + SC

Intervention Type OTHER

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

Drink A + CC

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.

Group Type EXPERIMENTAL

Drink A + CC

Intervention Type OTHER

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

Drink B + CC

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.

Group Type ACTIVE_COMPARATOR

Drink B + CC

Intervention Type OTHER

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

Drink C + CC

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.

Group Type ACTIVE_COMPARATOR

Drink C + CC

Intervention Type OTHER

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

Interventions

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Drink A + SC

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

Intervention Type OTHER

Drink B + SC

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

Intervention Type OTHER

Drink C + SC

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

Intervention Type OTHER

Drink A + CC

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

Intervention Type OTHER

Drink B + CC

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

Intervention Type OTHER

Drink C + CC

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

Intervention Type OTHER

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saint Vincent De Paul - French Hospital - Nazareth

UNKNOWN

Sponsor Role collaborator

Tel Hai College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lili Nimri, Dr.

Role: PRINCIPAL_INVESTIGATOR

Nutritional sciences Department Tel-Hai College

Locations

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Saint Vincent De Paul hospital

Nazareth, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Lili Nimri, Dr.

Role: CONTACT

972-547648223

Facility Contacts

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Bshara Mansour, Dr.

Role: primary

972-503030354

Other Identifiers

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TelHaiC-EDE

Identifier Type: -

Identifier Source: org_study_id

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