Cognitive ChangeNCT06062186
Acute Effects of Naturally Occurring Tea and Coffee-based Ingredients on Cognitive Performance
A study testing AmaTea Guayusa Extract and Lion's Mane in people with Cognitive Change, run by The Center for Applied Health Sciences, LLC at 1 site in United States.
Trial summary
This study is a double-blind, randomized, three-arm, single-dose, placebo-controlled crossover trial of forty (40) apparently healthy male and female participants. The objective of this study is to assess the effects of AmaTea Max Organic Guayusa Extract and Lion's Mane on cognitive responses including mental clarity… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- AmaTea Guayusa Extract and Lion's Mane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2023to 15 Sep 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide voluntary signed and dated informed consent.
- Be in good health and able to participate in cognitive performance testing as determined by assessment, medical history and routine blood chemistries.
- Between the of 18 and 50 years of age (inclusive).
- Body Mass Index of 18.5-39.9 (inclusive).
- Body weight of at least 110 pounds.
- Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
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- Normal supine, resting heart rate (<90 per minute).
- Able to provide an adequate blood draw.
- Habitually consumes ≤ 240 mg caffeine/day (equivalent of 3 cups of coffee). Dietary supplementation consistent over one month and able to maintain supplementation throughout study.
- If dietary supplement initiated within the past month, participant is willing to discontinue supplement use followed by a 2-week washout prior to participation in the study.
- Willing to duplicate their previous 24-hour diet, refrain from caffeine for 12 hours, refrain from exercise for 24 hours prior to each trial, and fast for 8 hours prior each of the treatments.
Who cannot join
- Current smoker or other nicotine use (i.e. vape, patch, etc.).
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- Prior gastrointestinal bypass surgery (Lapband, etc.).
- Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
- Chronic inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
- History of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
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- History of cognitive disorder.
- History of psychiatric disorder.
- Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of-Analysis.
- Women currently pregnant, trying to become pregnant or breastfeeding a child.
- Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Applied Health Sciences
Canfield, Ohio, 44406
About this study
This study is a double-blind, randomized, three-arm, single-dose, placebo-controlled crossover trial of forty (40) apparently healthy male and female participants. The objective of this study is to assess the effects of AmaTea Max Organic Guayusa Extract and Lion's Mane on cognitive responses including mental clarity, mood, focus, concentration, productivity, anxiety/stress, happiness, and accuracy.
Read the detailed description
This study is a double-blind, randomized, three-arm, single-dose, placebo-controlled crossover trial of forty (40) apparently healthy male and female participants. The objective of this study is to assess the effects of AmaTea Max Organic Guayusa Extract and Lion's Mane on cognitive responses including mental clarity, mood, focus, concentration, productivity, anxiety/stress, happiness, and accuracy. Since these dietary supplements are on the market for consumer use, it is important to investigate and confirm their potential benefits, comparisons, and safety through further research.
Subjects will attend 4 study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, routine blood work, background baseline diet). During Visits 2, 3 and 4, at 3 time points (pre-ingestion, 60 and 120 minutes post ingestion), participants will complete subjective baseline testing including questionnaires that assess mental clarity, mood, focus, concentration, productivity, anxiety/stress, and the Happiness Scale in addition to completing a series of objective neuropsychological tests (e.g., Go/no-go test, N-back test, Serial Sevens test) to assess cognitive performance. Safety will be monitored via vital signs (heart rate, blood pressure) and adverse events (AE) throughout study.
- Conditions
- Cognitive Change
- Being tested
- Placebo, AmaTea Guayusa Extract, Lion's Mane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
650 mg of placebo, given as two capsules containing maltodextrin
AmaTea Guayusa ExtractDietary supplement
650 mg of AmaTea Guayusa Extract, given as two capsules
Lion's ManeDietary supplement
1000 mg of Lion's Mane, given as two capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 650 mg of placebo, given as two capsules containing maltodextrin Receives: Dietary Supplement: Placebo |
| AmaTea Max Guayusa extract | Experimental | 650 mg of AmaTea Guayusa Extract, given as two capsules Receives: Dietary Supplement: AmaTea Guayusa Extract |
| Lion's Mane | Experimental | 1000 mg of Lion's Mane, given as two capsules Receives: Dietary Supplement: Lion's Mane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration
Concentration as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better concentration.
Measured: Change from baseline to 60 minutes and 120 minutes.
Mental Clarity
Mental clarity as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better mental clarity.
Measured: Change from baseline to 60 minutes and 120 minutes.
Mood
Mood as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better mood.
Measured: Change from baseline to 60 minutes and 120 minutes.
Focus
Focus as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better focus.
Measured: Change from baseline to 60 minutes and 120 minutes.
Productivity
Productivity as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better productivity.
Measured: Change from baseline to 60 minutes and 120 minutes.
Stress
Stress as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater stress.
Measured: Change from baseline to 60 minutes and 120 minutes.
Happiness
Happiness as measured by The Subjective Happiness Scale, where values can range from 4 to 28, and higher values represent greater happiness.
Measured: Change from baseline to 60 minutes and 120 minutes.
Cognitive Control
Cognitive control as measured by the Go/No-go Test.
Measured: Change from baseline to 60 minutes and 120 minutes.
Working Memory
Working memory as measured by the N-back Test.
Measured: Change from baseline to 60 minutes and 120 minutes.
Attention
Attention as measured by the Serial Sevens Test.
Measured: Change from baseline to 60 minutes and 120 minutes.
Secondary outcomes (3)
Systolic blood pressure
Systolic blood pressure in mm of mercury.
Measured: Change from baseline to 60 minutes and 120 minutes.
Diastolic blood pressure
Diastolic blood pressure in mm of mercury.
Measured: Change from baseline to 60 minutes and 120 minutes.
Heart rate
Heart rate measured in beats per minute.
Measured: Change from baseline to 60 minutes and 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start5 Apr 2023
- Primary completion28 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Applied Health Sciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Ziegenfuss, PhD, Principal investigator, The Center for Applied Health Sciences, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062186
- Sponsor's protocol ID
- AFS-04-2023-003
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Naturally Occurring Tea and Coffee-based Ingredients on Cognitive Performance
- ClinicalTrials.gov ID
- NCT06062186
- Acronym / sponsor ID
- AFS-04-2023-003
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Center for Applied Health Sciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 2 Oct 2023 (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.
This study is a double-blind, randomized, three-arm, single-dose, placebo-controlled crossover trial of forty (40) apparently healthy male and female participants. The objective of this study is to assess the effects of AmaTea Max Organic Guayusa Extract and Lion's Mane on cognitive responses including mental clarity, mood, focus, concentration, productivity, anxiety/stress, happiness, and accuracy.
Detailed description
This study is a double-blind, randomized, three-arm, single-dose, placebo-controlled crossover trial of forty (40) apparently healthy male and female participants. The objective of this study is to assess the effects of AmaTea Max Organic Guayusa Extract and Lion's Mane on cognitive responses including mental clarity, mood, focus, concentration, productivity, anxiety/stress, happiness, and accuracy. Since these dietary supplements are on the market for consumer use, it is important to investigate and confirm their potential benefits, comparisons, and safety through further research.
Subjects will attend 4 study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, routine blood work, background baseline diet). During Visits 2, 3 and 4, at 3 time points (pre-ingestion, 60 and 120 minutes post ingestion), participants will complete subjective baseline testing including questionnaires that assess mental clarity, mood, focus, concentration, productivity, anxiety/stress, and the Happiness Scale in addition to completing a series of objective neuropsychological tests (e.g., Go/no-go test, N-back test, Serial Sevens test) to assess cognitive performance. Safety will be monitored via vital signs (heart rate, blood pressure) and adverse events (AE) throughout study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo650 mg of placebo, given as two capsules containing maltodextrin |
| AmaTea Max Guayusa extract | Experimental | Dietary Supplement: AmaTea Guayusa Extract650 mg of AmaTea Guayusa Extract, given as two capsules |
| Lion's Mane | Experimental | Dietary Supplement: Lion's Mane1000 mg of Lion's Mane, given as two capsules |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Provide voluntary signed and dated informed consent.
- Be in good health and able to participate in cognitive performance testing as determined by assessment, medical history and routine blood chemistries.
- Between the of 18 and 50 years of age (inclusive).
- Body Mass Index of 18.5-39.9 (inclusive).
- Body weight of at least 110 pounds.
Key exclusion criteria (11 listed)
- Current smoker or other nicotine use (i.e. vape, patch, etc.).
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- Prior gastrointestinal bypass surgery (Lapband, etc.).
- Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
- Chronic inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
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 |
|---|---|---|
| Placebo650 mg of placebo, given as two capsules containing maltodextrin | Dietary supplement | Placebo |
| AmaTea Guayusa Extract650 mg of AmaTea Guayusa Extract, given as two capsules | Dietary supplement | AmaTea Max Guayusa extract |
| Lion's Mane1000 mg of Lion's Mane, given as two capsules | Dietary supplement | Lion's Mane |
Primary outcome
Concentration
Time frame: Change from baseline to 60 minutes and 120 minutes.
Concentration as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better concentration.
Mental Clarity
Time frame: Change from baseline to 60 minutes and 120 minutes.
Mental clarity as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better mental clarity.
Mood
Time frame: Change from baseline to 60 minutes and 120 minutes.
Mood as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better mood.
Focus
Time frame: Change from baseline to 60 minutes and 120 minutes.
Focus as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better focus.
Productivity
Time frame: Change from baseline to 60 minutes and 120 minutes.
Productivity as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better productivity.
Stress
Time frame: Change from baseline to 60 minutes and 120 minutes.
Stress as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater stress.
Happiness
Time frame: Change from baseline to 60 minutes and 120 minutes.
Happiness as measured by The Subjective Happiness Scale, where values can range from 4 to 28, and higher values represent greater happiness.
Cognitive Control
Time frame: Change from baseline to 60 minutes and 120 minutes.
Cognitive control as measured by the Go/No-go Test.
Working Memory
Time frame: Change from baseline to 60 minutes and 120 minutes.
Working memory as measured by the N-back Test.
Attention
Time frame: Change from baseline to 60 minutes and 120 minutes.
Attention as measured by the Serial Sevens Test.
3 secondary outcomes
Systolic blood pressure
Time frame: Change from baseline to 60 minutes and 120 minutes.
Diastolic blood pressure
Time frame: Change from baseline to 60 minutes and 120 minutes.
Heart rate
Time frame: Change from baseline to 60 minutes and 120 minutes.
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 2 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Tim Ziegenfuss, PhD principal investigator
The Center for Applied Health Sciences, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AmaTea Guayusa Extract and Lion's Mane in people with Cognitive Change, run by The Center for Applied Health Sciences, LLC 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 11 inclusion and 11 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 2 Oct 2023. 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?
Concentration (time frame: Change from baseline to 60 minutes and 120 minutes.). The study lists 10 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 2 Oct 2023.