The Effects of e+Shots Energy Beverage on Mental Energy

NCT ID: NCT03850275

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-26
• Study Completion Date: 2016-12-15

Brief Summary

The aim of the research project is to determine the changes in motivation to perform mental and physical tasks, feelings of vigor and fatigue, mental task vigilance and fine motor function after consumption of a commercially available energy product. The purpose of this study is determine whether e+shot, a product containing natural caffeine, will impact mood and performance up to 108 minutes post consumption compared to a sweetened solution containing synthetic caffeine.

Detailed Description

Enrolled participants who are low consumers of caffeine will be administered either a placebo (3mg caffeine), caffeinated placebo (~100mg of caffeine) or e+shot first and then will be crossed over to receive the other two interventions. The study consists of 3 treatment periods of 108 minutes each with a washout period of 48 hours.

Conditions

Caffeine

Study Design

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

Study Groups

Experimental: Placebo, then caffeinated placebo, then e+shots

Participants received placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the caffeinated placebo and tested for 108 minutes. After another 48 hour washout period they received the e+shot and were tested for 108 minutes

Group Type: EXPERIMENTAL

Intervention/treatment

Intervention Type: DIETARY_SUPPLEMENT

Subjects received all 3 interventions Placebo \~3mg caffeine Caffeinated placebo \~100mg caffeine E+shots- The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.

Experimental: Caffeinated placebo, then placebo, then e+shots

Participants received caffeinated placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the placebo and tested for 108 minutes. After another 48 hour washout period they received the e+shot and were tested for 108 minutes

Group Type: EXPERIMENTAL

Intervention/treatment

Intervention Type: DIETARY_SUPPLEMENT

Subjects received all 3 interventions Placebo \~3mg caffeine Caffeinated placebo \~100mg caffeine E+shots- The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.

Experimental: placebo, then e+shots, then caffeinated placebo

Participants received placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received e+shots and tested for 108 minutes. After another 48 hour washout period they received the caffeinated placebo and were tested for 108 minutes.

Group Type: EXPERIMENTAL

Intervention/treatment

Intervention Type: DIETARY_SUPPLEMENT

Subjects received all 3 interventions Placebo \~3mg caffeine Caffeinated placebo \~100mg caffeine E+shots- The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.

Experimental: caffeinated placebo, then e+shots, then placebo

Participants received caffeinated placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the e+shots and tested for 108 minutes. After another 48 hour washout period they received the placebo and were tested for 108 minutes.

Group Type: EXPERIMENTAL

Intervention/treatment

Intervention Type: DIETARY_SUPPLEMENT

Subjects received all 3 interventions Placebo \~3mg caffeine Caffeinated placebo \~100mg caffeine E+shots- The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.

Experimental: e+shots, then caffeinated placebo, then placebo

Participants received e+shots and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the caffeinated placebo and tested for 108 minutes. After another 48 hour washout period they received the placebo and were tested for 108 minutes.

Group Type: EXPERIMENTAL

Intervention/treatment

Intervention Type: DIETARY_SUPPLEMENT

Subjects received all 3 interventions Placebo \~3mg caffeine Caffeinated placebo \~100mg caffeine E+shots- The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.

Experimental: e+shots, then placebo, then caffeinated placebo

Participants received e+shots and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the placebo and tested for 108 minutes. After another 48 hour washout period they received the caffeinated placebo and were tested for 108 minutes.

Group Type: EXPERIMENTAL

Intervention/treatment

Intervention Type: DIETARY_SUPPLEMENT

Subjects received all 3 interventions Placebo \~3mg caffeine Caffeinated placebo \~100mg caffeine E+shots- The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.

Interventions

Intervention/treatment

Subjects received all 3 interventions Placebo \~3mg caffeine Caffeinated placebo \~100mg caffeine E+shots- The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Ages 18-45
• Body Mass Index (BMI) < 30
• Profile of Mood Status Short Scale (POMS) score <13 on the energy scale
• Energy and Fatigue trait scale score <=10
• Consumption of <200mg of caffeine/day
• Consumption of <150 servings of polyphenols/month

Exclusion Criteria

• Subjects taking prescription or over the counter medications (except for oral contraceptives) for a chronic medical condition or recreational drugs will be excluded Chronic medical conditions are any health condition that is expected to last more than 3 months and requires on going medical care such as coronary artery disease, multiple sclerosis, etc..
• Women who are pregnant or may be trying to become pregnant
• Women who are breastfeeding
• People who have been diagnosed with heart conditions and/or hypertension
• People who have liver disorders
• People who have sensitivity or allergy to caffeine
• People who have bipolar disorder
• People who have iron deficiency
• People who are allergic to plants of the Asteraceae/Compositae/Daisy family
• Day of testing

• Subjects who have had a change of ±2 hours of sleep from their regular sleep time will be re-scheduled.
• If subjects begin taking a prescription or over the counter medication for an acute condition (i.e. required to take the prescription or over the counter medication for < 3 months) during the study they will be given the option of continuing the study after they are no longer taking the prescription or over the counter medication or dropping out of the study.
• If subjects are diagnosed with a chronic condition that requires the use of prescription medications for > 3 months after they have started the study they will be eliminated from the study.
• Resting systolic BP > 180mmHg and diastolic BP > 90mmHg after consuming the caffeine beverage.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Isagenix International LLC

INDUSTRY

Sponsor Role: collaborator

Clarkson University

OTHER

Sponsor Role: lead

Responsible Party

Ali Boolani

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

16-05

Identifier Type: -

Identifier Source: org_study_id