Energy DrinksEDENCT04808128
The Effect of Energy Drinks Consumption on Acute Physiological and Psychological Responses of Israeli Arab Adolescents
A study testing Drink A + SC, Drink B + SC and Drink C + SC in people with Energy Drinks, run by Tel Hai College at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Drinks
- What is being tested?
- Drink A + SC, Drink B + SC and Drink C + SC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Oct 2020to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy
- Israeli Arab adolescents
- aged 14.5-17.5 years
Who cannot join
- diabetes
- hypoglycemic episodes
- coronary heart disease, cardiac arrhythmia, secondary hypertension, structural heart lesions
- hepatic or renal disorders
- autonomic neuropathy
- epilepsy
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- obstructive sleep apnea
- migraines
- caffeine intolerance
- eating disorders or other mental disorders or those with prescribed psychiatric medications
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Saint Vincent De Paul hospital
Nazareth, 16511
Bshara Mansour, Dr., 972-503030354, bsharaitaly@yahoo.com
About this study
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.
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
- Being tested
- Drink A + SC, Drink B + SC, Drink C + SC, Drink A + CC, Drink B + CC
- Keywords
- Energy drinks (EDs), Blood pressure (BP), Glucose tolerance, Metabolite profiles, Mood, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drink A + SCOther
Consumption of energy drink that contains 80mg caffeine and 27g carbohydrates per 250ml together with simple carbohydrates.
Drink B + SCOther
Consumption of soft drink, non-caffeine drink that contains 27g carbohydrates per 250ml together with simple carbohydrates.
Drink C + SCOther
Consumption of soda water, non-caffeine and non-carbohydrate drink together with simple carbohydrates.
Drink A + CCOther
Consumption of energy drink that contains 80mg caffeine and 27g carbohydrates per 250ml together with complex carbohydrates.
Drink B + CCOther
Consumption of soft drink, non-caffeine drink that contains 27g carbohydrates per 250ml together with complex carbohydrates.
Drink C + CCOther
Consumption of soda water, non-caffeine and non-carbohydrate drink together with complex carbohydrates.
| Study group | Role | What they receive |
|---|---|---|
| Drink A + SC | Experimental | In t0 the group will receive 250 ml XL energy drink + 20 gr sucrose. Receives: Other: Drink A + SC |
| Drink B + SC | Active comparator | In t0 the group will receive 250 ml Fanta soft drink + 20 gr sucrose. Receives: Other: Drink B + SC |
| Drink C + SC | Active comparator | In t0 the group will receive 250 ml soda water + 47 gr sucrose. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Drink C + CC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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).
Measured: 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
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.
Measured: During intervention, 60 minutes after consuming the meal.
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.
Measured: During intervention, 60 minutes after consuming the meal.
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.
Measured: During intervention, 60 minutes after consuming the meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start2 Oct 2020
- Primary completionApr 2021 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy DrinksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Hai College
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Vincent De Paul - French Hospital - Nazareth
- Responsible party
- Sponsor
- Investigators
- Lili Nimri, Dr., Principal investigator, Nutritional sciences Department Tel-Hai College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808128
- Sponsor's protocol ID
- TelHaiC-EDE
- Acronym
- EDE
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04808128
- Acronym / sponsor ID
- EDE / TelHaiC-EDE
- Conditions
- Energy Drinks
- Keywords
- Energy drinks (EDs), Blood pressure (BP), Glucose tolerance, Metabolite profiles, Mood, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tel Hai CollegeUniversity, hospital or other
- Collaborators
- Saint Vincent De Paul - French Hospital - Nazareth
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Drink A + SC | Experimental | Other: Drink A + SCIn t0 the group will receive 250 ml XL energy drink + 20 gr sucrose. |
| Drink B + SC | Active comparator | Other: Drink B + SCIn t0 the group will receive 250 ml Fanta soft drink + 20 gr sucrose. |
| Drink C + SC | Active comparator | Other: Drink C + SCIn t0 the group will receive 250 ml soda water + 47 gr sucrose. |
| Drink A + CC | Experimental | Other: Drink A + CCIn t0 the group will receive 250 ml XL energy drink + 20gr complex carbohydrates from one slice of bread (30g) and one spoon of hummus. |
| Drink B + CC | Active comparator | Other: Drink B + CCIn t0 the group will receive 250 ml Fanta soft drink + 20gr complex carbohydrates from one slice of bread (30g) and one spoon of hummus. |
| Drink C + CC | Active comparator | Other: Drink C + CCIn 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. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy
- Israeli Arab adolescents
- aged 14.5-17.5 years
Key exclusion criteria (10 listed)
- diabetes
- hypoglycemic episodes
- coronary heart disease, cardiac arrhythmia, secondary hypertension, structural heart lesions
- hepatic or renal disorders
- autonomic neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drink A + SCConsumption of energy drink that contains 80mg caffeine and 27g carbohydrates per 250ml together with simple carbohydrates. | Other | Drink A + SC |
| Drink B + SCConsumption of soft drink, non-caffeine drink that contains 27g carbohydrates per 250ml together with simple carbohydrates. | Other | Drink B + SC |
| Drink C + SCConsumption of soda water, non-caffeine and non-carbohydrate drink together with simple carbohydrates. | Other | Drink C + SC |
| Drink A + CCConsumption of energy drink that contains 80mg caffeine and 27g carbohydrates per 250ml together with complex carbohydrates. | Other | Drink A + CC |
| Drink B + CCConsumption of soft drink, non-caffeine drink that contains 27g carbohydrates per 250ml together with complex carbohydrates. | Other | Drink B + CC |
| Drink C + CCConsumption of soda water, non-caffeine and non-carbohydrate drink together with complex carbohydrates. | Other | Drink C + CC |
Primary outcome
Blood sugar change
Time frame: First measurement at baseline, before consuming the meal, and four times during the intervention - 15, 30, 60 and 120 minutes after consuming the meal
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).
Anxiety status
Time frame: During the intervention, 60 minutes after consuming the meal.
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.
Mood change
Time frame: First measurement at baseline, before consuming the meal, and another measurement during the intervention, 60 minutes after consuming the meal.
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.
Insulin levels status
Time frame: During the intervention, between 30-45 minutes after consuming the meal.
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.
SCFA levels status
Time frame: During the intervention, between 30-45 minutes after consuming the meal.
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.
HR change
Time frame: First measurement at baseline, before consuming the meal, and four times during the intervention - 15, 30, 60 and 120 minutes after consuming the meal
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.
4 secondary outcomes
BP change
Time frame: 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
Time frame: During intervention, 60 minutes after consuming the meal.
Energy drinks consumption status
Time frame: During intervention, 60 minutes after consuming the meal.
Caffeine consumption frequency
Time frame: During intervention, 60 minutes after consuming the meal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lili Nimri, Dr. principal investigator
Nutritional sciences Department Tel-Hai College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drink A + SC, Drink B + SC and Drink C + SC in people with Energy Drinks, run by Tel Hai College at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lili Nimri, Dr. (972-547648223, lili.nimri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood sugar change (time frame: First measurement at baseline, before consuming the meal, and four times during the intervention - 15, 30, 60 and 120 minutes after consuming the meal). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.