Mental EnergyNCT03870126
Dose Effect of a Plant Extract on Fatigue
A study testing Flavored beverage in people with Mental Energy and Physical Performance, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
Test the short-term effects of the acute consumption of two separate beverages containing different concentrations of polyphenols, a beverage containing 75 mg of caffeine and a flavored placebo beverage on mental energy and physical performance Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Energy, Physical Performance
- What is being tested?
- Flavored beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2019to 6 Dec 2019
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-49 years of age
- Self-report of good health
- Physical activity requirement: Recreationally active (exercise ≥3 times per week for >30 minutes per session; both cyclists and non-cyclists may enroll)
Who cannot join
- Under the care of a physician
- Visual impairment that cannot be corrected with glasses or contact lenses
- Inability to perform high intensity exercise (defined perceptually as exercise that feels at least "hard" and this is usually quantified using the Borg 6 to 20 scale. High intensity cycling exercise is defined objectively as exercise causing a high heart rate, defined as a heart rate that is equal to or greater than 70% of heart rate reserve.)
- Inability to adequately perform the cognitive tasks (i.e., cannot complete the task due to -inability to understand instructions or >50% incorrect responses)
- Presence of current or chronic gastrointestinal, sleep or psychiatric disorder
- Pregnant/lactating
Show all 14Show fewer
- Current smoker
- Report illegal drug use
- Report hypersensitivity to caffeine
- Food allergies/intolerances/sensitivities (including coffee or related foods/beverages/products)
- Current use of dietary supplements, or prescription medication except for oral contraceptives
- Unwillingness to abstain from over the counter medications (e.g. NSAIDS, allergy medications) and caffeine/coffee/foods high in polyphenols for 12 hours prior to the study
- Unwilling to refrain from consuming apple and grapefruit products on study days and 12 hours prior to test days.
- Participation in another clinical trial within the past 30 days or participation in another PepsiCo trial in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Two Doses of a Plant Extract on Mental and Physical Fatigue
Test the short-term effects of the acute consumption of two separate beverages containing different concentrations of polyphenols, a beverage containing 75 mg of caffeine and a flavored placebo beverage on mental energy and physical performance
- Conditions
- Mental Energy, Physical Performance
- Being tested
- Flavored beverage
- Keywords
- cognitive, phytochemicals, caffeine, polyphenol, beverage, exercise, mental performance, physical performance, vigilance, vigor, energy, vitality, fatigue, sports performance, high-intensity intermittent exercise
- Medical subject headings
- Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavored beverageOther
Consume one beverage at the beginning of each visit of the cross-over sequence
| Study group | Role | What they receive |
|---|---|---|
| Flavored Beverage Mix 1 | Placebo comparator | Flavored still beverage Receives: Other: Flavored beverage |
| Flavored Beverage Mix 2 | Experimental | Flavored still beverage with polyphenols, concentration 1 Receives: Other: Flavored beverage |
| Flavored Beverage Mix 3 | Experimental | Flavored still beverage with polyphenols, concentration 2 Receives: Other: Flavored beverage |
| Flavored Beverage Mix 4 | Experimental | Flavored still beverage with caffeine Receives: Other: Flavored beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective mental energy: Cognitive test battery
Changes in subjective measures of mental alertness and mental fatigue through computer administered cognitive test battery domains of short-term memory, attention and mood. Tasks are word presentation, word recognition, picture presentation, picture recognition, Cognitive Demand Battery (CDB) serial 3 and serial 7 subtraction, and Bakan task/Rapid Visual Information Processing (RVIP). Performance measures: % correct, % errors and response time in milliseconds.
Measured: Baseline and 60 min post treatment
Subjective mental energy: VAS for mental alertness
Changes in subjective ratings of mental alertness following computer administered cognitively fatiguing tasks. Visual Analog Scale (VAS) for mental alertness has the score range 0-100 (from not at all to extremely).
Measured: Baseline and 60 min post treatment
Subjective mental energy: VAS for motivation
Changes in subjective ratings of motivation following computer administered cognitively fatiguing tasks. Visual Analog Scale (VAS) for motivation has the score range 0-100 (from not at all to extremely).
Measured: Baseline and 60 min post treatment
Subjective mental energy: VAS for mental fatigue
Changes in subjective ratings of fatigue following computer administered cognitively fatiguing tasks. Visual Analog Scale (VAS) for fatigue has the score range 0-100 (from not at all to extremely).
Measured: Baseline and 60 min post treatment
Subjective mental and physical energy: VAS for mental and physical state and trait energy and fatigue (EFS State Scales)
Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks. Mental and Physical State and Trait Energy and Fatigue Scales (EFS State Scales) consist of 12 VAS items to measure intensity of current feeling of physical energy and fatigue and mental energy and fatigue (3 sub-scales each). Score range: The 3 items from each sub-scale are summed and scores for each sub-scale range from 0-300 (none to strongest).
Measured: Baseline and 60 min post treatment
Subjective mental energy: VAS for mood
Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks. The Bond-Lader test uses 16 Visual Analog Scales (VAS) to measure different aspects of mood, with score range 0-100 for each scale (from absence of feeling to presence of feeling).
Measured: Baseline and 60 min post treatment
Subjective mental energy: VAS for caffeine symptoms
Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks. Caffeine symptoms are measured on paper using 8 Visual Analog Scales (VAS) with score range 0-100 (from not at all to extremely).
Measured: Baseline and 60 min post treatment
Secondary outcomes (5)
Physical performance
Mean power output in a timed cycling trial following post-treatment cognitive test battery and caffeine symptom VAS.
Measured: During the last 3 minutes of 23 min high intensity cycling exercise (10 x 1 min work intervals each followed by 1 min rest. No rest after final interval, 3 min max power from minutes 20-23.
Physical Fatigue
Subjective categorical scale, score range 0-7, higher score indicates greater feeling of physical fatigue
Measured: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
Alertness
Subjective categorical scale, score range 1-7, higher score indicates greater alertness meaning a greater feeling of energy
Measured: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
Effort
Subjective categorical scale, Borg Ratings of Perceived Exertion (RPE) measures perception of effort, score range 6-20. Higher score indicates greater effort. 17 or greater generally indicates maximal effort
Measured: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
Quadriceps muscle pain
Subjective categorical scale with ratio-like properties, scale 0-10 with open-ended option for ratings greater than but proportional to 10. Higher scores indicate greater perception of pain in the quadriceps
Measured: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start29 Jan 2019
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental EnergyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick J O'Connor, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870126
- Sponsor's protocol ID
- PEP-1807
- Status last verified
- Jan 2020
- First submitted
- 26 Feb 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be kept securely at U. Georgia for several years and can be accessed upon request by contacting Dr. Pat O'Connor (poconnor@uga.edu)
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Doses of a Plant Extract on Mental and Physical Fatigue
- ClinicalTrials.gov ID
- NCT03870126
- Acronym / sponsor ID
- PEP-1807
- Conditions
- Mental Energy, Physical Performance
- Keywords
- cognitive, phytochemicals, caffeine, polyphenol, beverage, exercise, mental performance, physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 11 Mar 2019 (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.
Test the short-term effects of the acute consumption of two separate beverages containing different concentrations of polyphenols, a beverage containing 75 mg of caffeine and a flavored placebo beverage on mental energy and physical performance
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Flavored Beverage Mix 1 | Placebo comparator | Other: Flavored beverageFlavored still beverage |
| Flavored Beverage Mix 2 | Experimental | Other: Flavored beverageFlavored still beverage with polyphenols, concentration 1 |
| Flavored Beverage Mix 3 | Experimental | Other: Flavored beverageFlavored still beverage with polyphenols, concentration 2 |
| Flavored Beverage Mix 4 | Experimental | Other: Flavored beverageFlavored still beverage with caffeine |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-49 years of age
- Self-report of good health
- Physical activity requirement: Recreationally active (exercise ≥3 times per week for >30 minutes per session; both cyclists and non-cyclists may enroll)
Key exclusion criteria (14 listed)
- Under the care of a physician
- Visual impairment that cannot be corrected with glasses or contact lenses
- Inability to perform high intensity exercise (defined perceptually as exercise that feels at least "hard" and this is usually quantified using the Borg 6 to 20 scale. High intensity cycling exercise is defined objectively as exercise causing a high heart rate, defined as a heart rate that is equal to or greater than 70% of heart rate reserve.)
- Inability to adequately perform the cognitive tasks (i.e., cannot complete the task due to -inability to understand instructions or >50% incorrect responses)
- Presence of current or chronic gastrointestinal, sleep or psychiatric disorder
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 |
|---|---|---|
| Flavored beverageConsume one beverage at the beginning of each visit of the cross-over sequence | Other | Flavored Beverage Mix 1, Flavored Beverage Mix 2, Flavored Beverage Mix 3, Flavored Beverage Mix 4 |
Primary outcome
Subjective mental energy: Cognitive test battery
Time frame: Baseline and 60 min post treatment
Changes in subjective measures of mental alertness and mental fatigue through computer administered cognitive test battery domains of short-term memory, attention and mood. Tasks are word presentation, word recognition, picture presentation, picture recognition, Cognitive Demand Battery (CDB) serial 3 and serial 7 subtraction, and Bakan task/Rapid Visual Information Processing (RVIP). Performance measures: % correct, % errors and response time in milliseconds.
Subjective mental energy: VAS for mental alertness
Time frame: Baseline and 60 min post treatment
Changes in subjective ratings of mental alertness following computer administered cognitively fatiguing tasks. Visual Analog Scale (VAS) for mental alertness has the score range 0-100 (from not at all to extremely).
Subjective mental energy: VAS for motivation
Time frame: Baseline and 60 min post treatment
Changes in subjective ratings of motivation following computer administered cognitively fatiguing tasks. Visual Analog Scale (VAS) for motivation has the score range 0-100 (from not at all to extremely).
Subjective mental energy: VAS for mental fatigue
Time frame: Baseline and 60 min post treatment
Changes in subjective ratings of fatigue following computer administered cognitively fatiguing tasks. Visual Analog Scale (VAS) for fatigue has the score range 0-100 (from not at all to extremely).
Subjective mental and physical energy: VAS for mental and physical state and trait energy and fatigue (EFS State Scales)
Time frame: Baseline and 60 min post treatment
Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks. Mental and Physical State and Trait Energy and Fatigue Scales (EFS State Scales) consist of 12 VAS items to measure intensity of current feeling of physical energy and fatigue and mental energy and fatigue (3 sub-scales each). Score range: The 3 items from each sub-scale are summed and scores for each sub-scale range from 0-300 (none to strongest).
Subjective mental energy: VAS for mood
Time frame: Baseline and 60 min post treatment
Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks. The Bond-Lader test uses 16 Visual Analog Scales (VAS) to measure different aspects of mood, with score range 0-100 for each scale (from absence of feeling to presence of feeling).
Subjective mental energy: VAS for caffeine symptoms
Time frame: Baseline and 60 min post treatment
Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks. Caffeine symptoms are measured on paper using 8 Visual Analog Scales (VAS) with score range 0-100 (from not at all to extremely).
5 secondary outcomes
Physical performance
Time frame: During the last 3 minutes of 23 min high intensity cycling exercise (10 x 1 min work intervals each followed by 1 min rest. No rest after final interval, 3 min max power from minutes 20-23.
Physical Fatigue
Time frame: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
Alertness
Time frame: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
Effort
Time frame: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
Quadriceps muscle pain
Time frame: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Yes. IPD will be kept securely at U. Georgia for several years and can be accessed upon request by contacting Dr. Pat O'Connor (poconnor@uga.edu)
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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.
Patrick J O'Connor, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavored beverage in people with Mental Energy and Physical Performance, run by PepsiCo Global R&D at 1 site in United States.
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 14 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: finished, as of the sponsor's last update on 18 Jan 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective mental energy: Cognitive test battery (time frame: Baseline and 60 min post treatment). The study lists 7 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 18 Jan 2020.