Health BehaviorNCT04895800
An Evaluation of the Effects of a Non-Caffeinated Energy Dietary Supplement
A study testing Phytovive and Caffeine in people with Health Behavior, run by Nova Southeastern University at 1 site in United States.
Trial summary
This study tested the effects of a botanical blend to a caffeine and a placebo condition on 1) self-reported alertness, anxiety, and headaches 2) multiple measures of attention 3) physical performance and 4) stress biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Phytovive and Caffeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2020to 15 Mar 2021
- 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
- Adult males and females from 18 to 50 years (inclusive) of age who are physically active and have been engaging in athletic and sporting endeavors consistently over a period of 6 months at minimum
- BMI 18.0 (normal) to 34.9 (obese, class I) kg/ m2 inclusive
- Agrees to maintain a stable lifestyle with no change in exercise or diet for the duration of the study
- Current consumer of caffeine either through caffeinated beverages or foods
- Non-smoker
- Able to physically exercise, to run on a treadmill at moderate to high intensity for a brief time (typically less than 20 min)
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- Participants with normal blood pressure or participants with hypertension that is controlled (BP < 160/90 and who are on medication at a stable dose (same dose for ≥90 days)
- Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, carry out all study-related procedures, communicate effectively with the study staff.
- Females must be using an acceptable method of contraception such as: abstinence, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream), intrauterine device or hormonal contraception (oral, injectable, implantable, transdermal, or vaginal) used consecutively for at least 3 months prior to screening visit, vasectomized partner or use of implants for at least 6 months prior to screening visit; bilateral tubal ligation, hysterectomy, bilateral oophorectomy, or be postmenopausal status with amenorrhea (no menses) for at least 1 year prior to the screening visit.
Who cannot join
- Have a known sensitivity or allergy to any of the study products or their ingredients
- Have any medical condition or disease based on the professional judgement and experience of the principal investigator (PI) plus research industry standards that might affect or impact the administration of study products
- Lactating, pregnant or planning to become pregnant during the study
- History of drug or alcohol abuse in the 12 months prior to screening
- History of psychiatric illness requiring hospitalization in the 6 months prior to screening
- History of diabetes (Type I or II) or uncontrolled hypertension (either systolic BP >160 or diastolic BP >90)
- Participation in or use of a research IP within 30 days prior to screening (cannot have been in another study within 30 days of screening)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Effects of a Non-Caffeinated Energy Die-tary Supplement on Cognitive and Physical Performance: A Randomized Double-Blind Placebo-Controlled Study
This study tested the effects of a botanical blend to a caffeine and a placebo condition on 1) self-reported alertness, anxiety, and headaches 2) multiple measures of attention 3) physical performance and 4) stress biomarkers.
Read the detailed description
This study aimed to build on this work by investigating the possibility that a specific botanical blend (Phytovive™); comprised of Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins) could improve cognitive and physical performance. To this end, this study was a randomized, double-blind, placebo-controlled 21-day parallel study on 36 healthy adults. The study compared the effects of the botanical blend at baseline to a caffeine and a placebo condition on 1) self-reported alertness, anxiety, and headaches 2) multiple measures of attention 3) physical performance and 4) stress biomarkers.
- Conditions
- Health Behavior
- Being tested
- Phytovive, Placebo, Caffeine
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhytoviveDietary supplement
Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins)
PlaceboDietary supplement
Natural Flavors [Chocolate, Caramel, Vanilla Cream], Silica, Inulin, Sucralose)
CaffeineDietary supplement
Caffeine (Green tea caffeine extract (170 mg; to deliver 34 mg caffeine [20% natural caf-feine])
| Study group | Role | What they receive |
|---|---|---|
| Herbal Supplement | Experimental | (Phytovive™); comprised of Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins) Receives: Dietary Supplement: Phytovive |
| Caffeine | Active comparator | Green tea caffeine extract (170 mg; to deliver 34 mg caffeine [20% natural caffeine]), Receives: Dietary Supplement: Caffeine |
| Placebo | Placebo comparator | Flavored placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
Cognitive performance on the NIH Toolbox Cognition Battery and Joggle Psychomotor Vigilance Task. T scores (higher is better) will be reported.
Measured: 21 days
Mood
Self-reported Mood using the Mood and Physical Sensation Scale (higher scores reflect better mood)
Measured: 21 Days
Physical Performance
Time to Exhaustion (TTE) Test - running on a treadmill with an increased incline every minute until perceived exhaustion is reached
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start3 Jan 2020
- Primary completion20 Jan 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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
- Parallel groups
- Model description
- A Randomized Double-Blind Placebo-Controlled Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Tartar, Nova Southeastern University
- Investigators
- Jaime Tartar, Ph.D., Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895800
- Sponsor's protocol ID
- 2019-563
- Status last verified
- Jun 2021
- First submitted
- 17 May 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kongkeaw C, Dilokthornsakul P, Thanarangsarit P, Limpeanchob N, Norman Scholfield C. Meta-analysis of randomized controlled trials on cognitive effects of Bacopa monnieri extract. J Ethnopharmacol. 2014;151(1):528-35. doi: 10.1016/j.jep.2013.11.008. Epub 2013 Nov 16.
PubMed 24252493Heaton RK, Akshoomoff N, Tulsky D, Mungas D, Weintraub S, Dikmen S, Beaumont J, Casaletto KB, Conway K, Slotkin J, Gershon R. Reliability and validity of composite scores from the NIH Toolbox Cognition Battery in adults. J Int Neuropsychol Soc. 2014 Jul;20(6):588-98. doi: 10.1017/S1355617714000241. Epub 2014 Jun 24.
PubMed 24960398Pickering C, Kiely J. What Should We Do About Habitual Caffeine Use in Athletes? Sports Med. 2019 Jun;49(6):833-842. doi: 10.1007/s40279-018-0980-7.
PubMed 30173351
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effects of a Non-Caffeinated Energy Die-tary Supplement on Cognitive and Physical Performance: A Randomized Double-Blind Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT04895800
- Acronym / sponsor ID
- 2019-563
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 20 May 2021 (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 tested the effects of a botanical blend to a caffeine and a placebo condition on 1) self-reported alertness, anxiety, and headaches 2) multiple measures of attention 3) physical performance and 4) stress biomarkers.
Detailed description
This study aimed to build on this work by investigating the possibility that a specific botanical blend (Phytovive™); comprised of Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins) could improve cognitive and physical performance. To this end, this study was a randomized, double-blind, placebo-controlled 21-day parallel study on 36 healthy adults. The study compared the effects of the botanical blend at baseline to a caffeine and a placebo condition on 1) self-reported alertness, anxiety, and headaches 2) multiple measures of attention 3) physical performance and 4) stress biomarkers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A Randomized Double-Blind Placebo-Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Herbal Supplement | Experimental | Dietary Supplement: Phytovive(Phytovive™); comprised of Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins) |
| Caffeine | Active comparator | Dietary Supplement: CaffeineGreen tea caffeine extract (170 mg; to deliver 34 mg caffeine [20% natural caffeine]), |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboFlavored placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adult males and females from 18 to 50 years (inclusive) of age who are physically active and have been engaging in athletic and sporting endeavors consistently over a period of 6 months at minimum
- BMI 18.0 (normal) to 34.9 (obese, class I) kg/ m2 inclusive
- Agrees to maintain a stable lifestyle with no change in exercise or diet for the duration of the study
- Current consumer of caffeine either through caffeinated beverages or foods
- Non-smoker
Key exclusion criteria (7 listed)
- Have a known sensitivity or allergy to any of the study products or their ingredients
- Have any medical condition or disease based on the professional judgement and experience of the principal investigator (PI) plus research industry standards that might affect or impact the administration of study products
- Lactating, pregnant or planning to become pregnant during the study
- History of drug or alcohol abuse in the 12 months prior to screening
- History of psychiatric illness requiring hospitalization in the 6 months prior to screening
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 |
|---|---|---|
| PhytoviveBacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins) | Dietary supplement | Herbal Supplement |
| PlaceboNatural Flavors [Chocolate, Caramel, Vanilla Cream], Silica, Inulin, Sucralose) | Dietary supplement | Placebo |
| CaffeineCaffeine (Green tea caffeine extract (170 mg; to deliver 34 mg caffeine [20% natural caf-feine]) | Dietary supplement | Caffeine |
Primary outcome
Cognition
Time frame: 21 days
Cognitive performance on the NIH Toolbox Cognition Battery and Joggle Psychomotor Vigilance Task. T scores (higher is better) will be reported.
Mood
Time frame: 21 Days
Self-reported Mood using the Mood and Physical Sensation Scale (higher scores reflect better mood)
Physical Performance
Time frame: 21 Days
Time to Exhaustion (TTE) Test - running on a treadmill with an increased incline every minute until perceived exhaustion is reached
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 9 Jun 2021.
- Background: PubMed 24252493Kongkeaw C, Dilokthornsakul P, Thanarangsarit P, Limpeanchob N, Norman Scholfield C. Meta-analysis of randomized controlled trials on cognitive effects of Bacopa monnieri extract. J Ethnopharmacol. 2014;151(1):528-35. doi: 10.1016/j.jep.2013.11.008. Epub 2013 Nov 16.
- Background: PubMed 24960398Heaton RK, Akshoomoff N, Tulsky D, Mungas D, Weintraub S, Dikmen S, Beaumont J, Casaletto KB, Conway K, Slotkin J, Gershon R. Reliability and validity of composite scores from the NIH Toolbox Cognition Battery in adults. J Int Neuropsychol Soc. 2014 Jul;20(6):588-98. doi: 10.1017/S1355617714000241. Epub 2014 Jun 24.
- Background: PubMed 30173351Pickering C, Kiely J. What Should We Do About Habitual Caffeine Use in Athletes? Sports Med. 2019 Jun;49(6):833-842. doi: 10.1007/s40279-018-0980-7.
- Individual participant dataSharing planned: No
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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.
Jaime Tartar, Ph.D. principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phytovive and Caffeine in people with Health Behavior, run by Nova Southeastern University 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 9 inclusion and 7 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 9 Jun 2021. 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?
Cognition (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04895800, which also lists 3 linked publications.
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 9 Jun 2021.