Effects of Energy Drinks

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Energy Drinks

Treatments: Other: Placebo; Dietary Supplement: Energy drink

Study type: Interventional

Funder types: Other

Identifiers

NCT02727920

00006831

Details and patient eligibility

About

This study is designed to test the efficacy of energy drinks. This is a double-blinded, crossover, randomized clinical trial, measuring the effect of the test drinks compared with placebo drink in 200 participants aged 18-70 years.

Full description

This study is designed to test the efficacy of an energy drink compared to placebo via a double-blind, crossover, randomized clinical trial. Energy levels will be assessed before and after consumption of the test beverages on 2 days separated by a week in 200 participants aged 18-70 years. The study is crossover because the participants will be (randomly) receiving one drink on Test Day 1 and the other drink on Test Day 2.

After signing written informed consent, participants will be fed a light lunch, and their pulse, weight and height measured. A baseline battery of computer-based tests to assess energy levels will be conducted. These computer-based measures will take ~40 minutes to complete and will include: a) a long-term memory test b) a Profile of Mood States (POMS2) brief form; c) Rapid Visual Information Processing (RVIP) test, d) The N-Back Task; d) Reaction time online test; f) the Flanker Task. Participants will then be asked to fill out a baseline survey (30 min), with questions about current health-related behaviors, specifically questions about physical activity and diet.

Upon completing the baseline battery (survey administered at test session 1 only), participants will be randomly administered the energy drink or the placebo to consume while observed. Subsequently, the battery of computer-based tests to assess energy levels will be re-administered 30 minutes, 2.5 hours and 5 hours after consumption of the test drink.

The study intervention will be double-blinded: participants will be blinded to whether they are receiving the active or the placebo drink, and study team members will also not be aware of the assignment.

When the study ends, full compensation will be given if the intervention is fully completed; if the intervention is not fully completed, partial compensation will be given.

Enrollment: 228 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Fluent in reading English
• High school graduate as lowest education level

Exclusion criteria

• Non-smoker
• No diagnosed/treated cognitive/psychiatric conditions by self-report
• No diagnosed/treated diabetes, hypoglycemia or thyroid condition by self-report
• No current use of prescription stimulant medications by self-report
• No allergies or sensitivities to foods, ingredients or chemicals by self-report, that are contained in the test drink or placebo
• No diagnosed phenylketonuria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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228 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

drink containing pyridoxine, folate; B12); taurine, choline, glucuronic acid; tyrosine, phenylalanine\*, malic acid, and caffeine administered one time.

Treatment:

Dietary Supplement: Energy drink

Placebo drink

Placebo Comparator group

Description:

Placebo drink administered one time.

Treatment:

Other: Placebo