Investigation of Dietary Supplement Liquid Shot Products on Mental Energy, Cognition (Acuity),and… (NCT06384586) | Clinical Trial Compass
CompletedNot Applicable
Investigation of Dietary Supplement Liquid Shot Products on Mental Energy, Cognition (Acuity),and Mood
United States45 participantsStarted 2022-11-17
Plain-language summary
This is a single center, randomized, double blind, placebo-controlled, crossover study to determine the acute effect of a developmental dietary supplement liquid shot product on cognitive task performance and perceived effect measures related to mood and mental energy. The study will be conducted in healthy participants.
Who can participate
Age range
18 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants must be willing to abstain from alcohol, caffeine and exercise starting from the night before each session.
. Participants that, on average, consume between 200 and 500 mgs of caffeine per day.
. Participants that are in good physical and mental health.
. Participants that are willing to come in-person and be within less than 6 feet of study staff for a short period of time.
. Participants that are able to provide written informed consent to participate in the study and will have agreed to abide by the study restrictions, requirements and protocol.
. Participants must, in the opinion of the Principal Investigator (or designee), demonstrate the ability to comprehend the informed consent form (ICF), be able to communicate well with the Investigator, understand and comply with the requirements of the study, and be judged suitable for the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mental energy via Cognitive Demand Battery (CDB) Performance Index; for the functional energy shot versus placebo shot.
Timeframe: Change from baseline to 120 min post- shot consumption
. Participants must be available to complete the study.
. Participants must be willing to consume a normal-sized meal (participant responsible for obtaining or preparing the meal) at least one hour prior to the start of the study session and then fast from food and beverage consumption (except water), for one hour prior to each research session.
Exclusion criteria
. Participants that are not US citizens or are residents of California.
. Participants that have a medical condition, including but not limited to heartbeat/rhythm irregularities, past heart attacks, been diagnosed with heart disease, seizure disorder, liver condition, blood clotting disorder, endocrine-related medical diagnosis (such as diabetes, thyroid, etc.), serious health condition (i.e. cancer, etc.), blindness, gastrointestinal sensitivity/condition, depression, insomnia, anxiety, hypertension, PKU (Phenylketonuria), Celiac disease or deafness. If a participant has any other medical condition or metabolic condition that prevents them from being able to fast for one hour, they will not be allowed to participate in this study.
. Participants that have a loss of taste or smell or are currently suffering from a virus/infection that affects their ability to taste or smell.
. Participants that are left-handed, have dyscalculia, have paralysis which effects the upper body, or are color-blind, as this could impact their ability to complete the cognitive tasks.
. Participants that use recreational drugs or that are currently taking medication (except for a contraceptive), or other drugs including non-prescription (over the counter) medications, pseudoephedrine, non-prescription painkillers such as paracetamol (acetaminophen), ibuprofen or aspirin.
. Participants that are taking green tea extract or any diet medications, appetite suppressors or supplements (including, but not limited to, fitness supplements containing green tea extract and caffeine, and workout supplements that are intended to assist with weight loss (such as phentermine)).
. Participants that are pregnant, breastfeeding (or pumping/expressing) or intend to become pregnant in the next six months.