Normal ControlsNCT02095301
Herbal Extract Study
A study testing Herbal Beverage in people with Normal Controls, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
The objective of this study is to assess the effects of an herbal extract on mental energy in healthy human subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Controls
- What is being tested?
- Herbal Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 2014
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is male or female, 18-70 years of age, inclusive.
- Subject has a body mass index (BMI) ≥17.0 and ≤32.9 kg/m2 at visit 1 (day -14 to -2).
- Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history, and routine laboratory test results.
- Subject is a non-smoker, defined as no tobacco use for ≥6 months prior to visit 1 (day -14 to -2).
- Individual is willing to maintain a habitual diet and physical activity patterns throughout the study period.
- Subject is willing to consume study product and standardized meals.
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- Individual is willing to abstain from caffeinated beverages and other caffeine-containing products for 12 h prior to all test visits (visits 2, 3, and 4; days 0, 3, and 6).
- Subject is willing to abstain from alcohol consumption and avoid non-routine vigorous physical activity for 24 h prior to all test visits (visits 2, 3, and 4; days 0, 3, and 6).
- Subject is willing to discontinue any vitamin/mineral or dietary supplements use for 2 weeks prior to visit 2 (day 0) and throughout the study period.
- Subject is a female who is willing to schedule the randomization visit (visit 2, day 0) during the luteal phase of her menstrual cycle, defined as days 15 to the end of the cycle, where day 1 is the first day of menses, where appropriate.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- Subject is unable to understand and/or perform required tests and questionnaires (i.e., subjects cannot complete the practice tests, or tasks).
- Subject is color blind.
- Subject has an abnormal laboratory test result of clinical significance, including, but not limited to creatinine ≥1.5 mg/dL and ALT or AST ≥1.5X upper limit of normal at visit 1 (day -14 to -2).
- Subject has a known allergy or sensitivity to study products or any ingredients of the study products, standardized meals/snacks provided.
- Subject has a gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).
- Subject has diagnosed depression, schizophrenia, or dementia in the last 2 years prior to visit 1 (day -14 to -2).
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- Subject has a history or presence of clinically important cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, and/or stroke), renal, hepatic, endocrine (including type 1 or type 2 diabetes mellitus), pulmonary, biliary, pancreatic, or neurologic disorders.
- Subject has extreme dietary habits (e.g., vegan, Atkins diet, very high protein).
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the blood pressure measured at visit 1, (day -14 to -2). One re-test will be allowed on a separate day prior to visit 2 (day 0) for subjects whose blood pressure exceeds either of these cut points at visit 1.
- Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Subject has signs/symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory infection). Test visits (visits 2, 3, and 4; days 0, 3, and 6) will be re-scheduled to allow subject to be symptom-free of any type of systemic infection for at least 5 d.
- Subject has recently used antibiotics (within 5 d of any test visit; Appendix 1). Test days (visits 2, 3, and 4; days 0, 3, and 6) will be rescheduled to allow the subject to be free of antibiotic therapy for at least 5 d.
- Subject has a history of use of psychotropic medications within 6 months of visit 2 (day 0) and throughout study period.
- Subject has used any other prescription medications, including over-the-counter medications within 2 weeks of visit 2 (day 0; Appendix 1) and throughout study period.
- Subject has used any over-the-counter or prescription sleep aid products (including dietary supplements) within 2 weeks of visit 2 (day 0) and throughout study period.
- Subject has a diagnosed sleep disorder (e.g., sleep apnea) or occupation where sleep during the overnight hours is irregular (e.g., 3rd shift or overnight workers).
- Subject consumes excessive amounts of caffeine (>4 cups of caffeinated coffee/d or >400 mg caffeine/d from caffeine-containing products).
- Subject is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.
- Subject has a recent history of (within 12 months of screening; visit 1, day -14 to -2) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Subject has been exposed to any non-registered drug product within 30 d prior to screening.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to assess the effects of an herbal extract on mental energy in healthy human subjects.
- Conditions
- Normal Controls
- Being tested
- Herbal Beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal BeverageOther
| Study group | Role | What they receive |
|---|---|---|
| Control plus herbal extract | Experimental | Control plus herbal extract Receives: Other: Herbal Beverage |
| Caffeine-free, carbonated soft drink | Placebo comparator | Caffeine-free, carbonated soft drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the ratings from computer administered tasks within the domains of mood, short-term recognition memory, and attention from pre- to post-study product consumption and between treatment conditions of an herbal extract
Measured: 0-2 hours
Secondary outcomes (1)
Measure plasma nutrient metabolites
Measured: 0-7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal ControlsStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095301
- Sponsor's protocol ID
- PEP-1320
- Status last verified
- Apr 2014
- First submitted
- 10 Mar 2014
- Last updated
- 22 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herbal Extract Study
- ClinicalTrials.gov ID
- NCT02095301
- Acronym / sponsor ID
- PEP-1320
- Conditions
- Normal Controls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 24 Mar 2014 (estimated)
- 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.
The objective of this study is to assess the effects of an herbal extract on mental energy in healthy human subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control plus herbal extract | Experimental | Other: Herbal BeverageControl plus herbal extract |
| Caffeine-free, carbonated soft drink | Placebo comparator | –Caffeine-free, carbonated soft drink |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is male or female, 18-70 years of age, inclusive.
- Subject has a body mass index (BMI) ≥17.0 and ≤32.9 kg/m2 at visit 1 (day -14 to -2).
- Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history, and routine laboratory test results.
- Subject is a non-smoker, defined as no tobacco use for ≥6 months prior to visit 1 (day -14 to -2).
- Individual is willing to maintain a habitual diet and physical activity patterns throughout the study period.
Key exclusion criteria (21 listed)
- Subject is unable to understand and/or perform required tests and questionnaires (i.e., subjects cannot complete the practice tests, or tasks).
- Subject is color blind.
- Subject has an abnormal laboratory test result of clinical significance, including, but not limited to creatinine ≥1.5 mg/dL and ALT or AST ≥1.5X upper limit of normal at visit 1 (day -14 to -2).
- Subject has a known allergy or sensitivity to study products or any ingredients of the study products, standardized meals/snacks provided.
- Subject has a gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).
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 |
|---|---|---|
| Herbal Beverage | Other | Control plus herbal extract |
Primary outcome
Changes in the ratings from computer administered tasks within the domains of mood, short-term recognition memory, and attention from pre- to post-study product consumption and between treatment conditions of an herbal extract
Time frame: 0-2 hours
1 secondary outcome
Measure plasma nutrient metabolites
Time frame: 0-7 hours
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 22 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal Beverage in people with Normal Controls, 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 11 inclusion and 21 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 22 Apr 2014. 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?
Changes in the ratings from computer administered tasks within the domains of mood, short-term recognition memory, and attention from pre- to post-study product consumption and between treatment conditions of an herbal extract (time frame: 0-2 hours). 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 22 Apr 2014.