Investigation of Dietary Supplement Liquid Shot Products on Mental Energy, Cognition (Acuity),and Mood

NCT ID: NCT06384586

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-17
• Study Completion Date: 2022-12-22

Brief 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.

Conditions

Cognition; Mental Fatigue; Mood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo 60 ml Shot, matched in volume, taste and colour and did not contain any active ingredients. 1 shot to be consumed per session

Group Type: PLACEBO_COMPARATOR

Placebo shot

Intervention Type: DIETARY_SUPPLEMENT

60ml shot served in an amber bottle and consumed after 40 minutes of baseline assessments

Functional energy shot

Intervention Type: DIETARY_SUPPLEMENT

60ml shot served in an amber bottle and consumed after 40 minutes of baseline assessments

Functional Energy shot

60ml functional energy shot contained a proprietary blend of caffeine, ginseng, vitamins and taurine. 1 shot to be consumed per session

Group Type: EXPERIMENTAL

Placebo shot

Intervention Type: DIETARY_SUPPLEMENT

60ml shot served in an amber bottle and consumed after 40 minutes of baseline assessments

Functional energy shot

Intervention Type: DIETARY_SUPPLEMENT

60ml shot served in an amber bottle and consumed after 40 minutes of baseline assessments

Interventions

Placebo shot

60ml shot served in an amber bottle and consumed after 40 minutes of baseline assessments

Intervention Type: DIETARY_SUPPLEMENT

Functional energy shot

60ml shot served in an amber bottle and consumed after 40 minutes of baseline assessments

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Participants must be willing to abstain from alcohol, caffeine and exercise starting from the night before each session.

2. Participants that, on average, consume between 200 and 500 mgs of caffeine per day.

3. Participants that are in good physical and mental health.

4. Participants that are willing to come in-person and be within less than 6 feet of study staff for a short period of time.

5. 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.

6. 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.

7. Participants must be available to complete the study.

8. 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

1. Participants that are not US citizens or are residents of California.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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)).

7. Participants that are pregnant, breastfeeding (or pumping/expressing) or intend to become pregnant in the next six months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HCD Research

INDUSTRY

Sponsor Role: collaborator

British American Tobacco (Investments) Limited

INDUSTRY

Sponsor Role: collaborator

The Water Street Collective

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle M Niedziela, PhD

Role: PRINCIPAL_INVESTIGATOR

HCD Research

Locations

Schlesinger Group New Jersey

Iselin, New Jersey, United States

Countries

United States

References

O'Shea OK, Lawley N, Azzopardi A, Gutkowski A, Niedziela MM, Horn R, Kennedy DO, Adamson J. Acute beneficial effects of a functional energy shot on cognitive performance and mood states during cognitively demanding task performance: a randomized, double-blind, placebo-controlled, crossover trial. Front Nutr. 2025 Jan 9;11:1496092. doi: 10.3389/fnut.2024.1496092. eCollection 2024.

Reference Type: DERIVED

PMID: 39850336 (View on PubMed)

Other Identifiers

CD J8855

Identifier Type: -

Identifier Source: org_study_id