AttentionPhase 1NCT01143194
A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Effects of Three Doses of the Dietary Supplement oréVida™ on Alertness, Attention and Concentration in Healthy Men and Women
A Phase 1 study testing oréVida™ in people with Attention and Memory, run by dsm-firmenich Switzerland AG at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of the dietary supplement oréVida™ (active ingredient on the basis of a culinary herb)administered twice daily in an acute study on an improvement in vigilance, attention, concentration, memory and mood in 45 healthy men and pre-menopausal women, aged 35-50… Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- What is being tested?
- oréVida™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Nov 2010
- Phase
- Phase 1
- 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 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a male or pre-menopausal female, 35-50 years, inclusive. Post-menopausal is defined as a history of spontaneous amenorrhea for a period of 12 consecutive months or six weeks post-surgical bilateral oophorectomy, with or without hysterectomy.
- Subject is willing to maintain his or her habitual diet and usual physical activity patterns throughout the study.
- 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 has a body mass index (BMI) of ≥20.00 and <30.00 kg/m2
- Subject is willing to refrain from consuming alcohol 24 h prior to test days.
- Subject is willing to refrain from consuming caffeine and caffeine-containing products 12 h prior to test days.
Show all 9Show fewer
- Subject is willing to refrain from vigorous physical activity 12 h prior to test days.
- Subject is a non-smoker.
- 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 has a positive drug screening of amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, methamphetamines, methadone, 3,4-methylenedioxymethamphetamine, opiates or tricyclic antidepressants at screening.
- Subject has abnormal laboratory test results of clinical significance, including, but not limited to: creatinine ≥1.5 mg/dL, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5X the upper limit of normal at screening.
- Subject has donated more than 300 mL of blood during the three months prior to screening.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the average blood pressure measured at screening. 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 clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorders that, in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.
- Subject has a history, in the judgment of the Investigator, of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
Show all 17Show fewer
- Use of any sleep aid medication within four days prior to each test day.
- Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- Subject is pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are 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 documentation.
- Excessive habitual caffeine consumption (>300 mg caffeine/d or ≥3 cups of caffeinated coffee/d), following screening and throughout the study period.
- Use of any psychotropic medication within four weeks of screening and throughout the study.
- Use of antibiotics or signs of active systemic infection. Treatment visits will be rescheduled to allow the subject to wash off of the antibiotic for at least five days prior to any test visit.
- Subject has had exposure to any non-registered drug product within 30 days prior to the screening visit.
- Use of dietary supplements containing any of the following: ginkgo biloba, St. John's wort, ginseng, gotu kola (Indian pennywort); daily doses of vitamin E (≥30 mg/d) or folic acid (≥400 ug/d); thiamine, riboflavin, and/or pyridoxine (≥2 mg/d); and eicosapentaenoic acid (EPA), docosahexaenoic acid or a combination of EPA + DHA (≥500 mg/d) within 2 weeks of screening visit.
- Recent history of (within 12 months of screening visit 1) 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 a known allergy or sensitivity to study product or any ingredients of the study product or meals provided.
- The subject is unable to perform the tests on the CDR System during training to the established acceptable levels for participation in this type of study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Provident Clinical Research
Addison, Illinois, 60101
About this study
The purpose of this study is to investigate the effects of the dietary supplement oréVida™ (active ingredient on the basis of a culinary herb)administered twice daily in an acute study on an improvement in vigilance, attention, concentration, memory and mood in 45 healthy men and pre-menopausal women, aged 35-50 years, inclusive.
oréVida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. We do not claim that this supplement is meant to treat any ailment.
- Being tested
- oréVida™, Placebo
- Keywords
- Attention, Vigilance, Concentration, Memory, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oréVida™Dietary supplement
1 capsule 30 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 60 mg/day)
oréVida™Dietary supplement
1 capsule 60 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 120mg/day)
oréVida™Dietary supplement
1 capsule 120 mg oréVida™ in the morning, one placebo capsule in the afternoon (si in total 120 mg/day)
PlaceboDietary supplement
1 capsule of placebo twice a day
| Study group | Role | What they receive |
|---|---|---|
| oréVida™ 60mg/day | Experimental | Not described Receives: Dietary Supplement: oréVida™ |
| oréVida™ 120mg/day (1) | Experimental | Not described Receives: Dietary Supplement: oréVida™ |
| oréVida™ 120mg/day (2) | Experimental | Not described Receives: Dietary Supplement: oréVida™ |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vigilance, Attention, and Concentration Tasks
Cognitive Drug Research (CDR) Test Battery Attention:
- Simple Reaction Time (Speed (msec))
- Digit Vigilance (Speed (msec)/ Targets detected (%))
- Choice Reaction Time(Speed (msec))
Measured: 4 times one day (at each test day, tasks 13 times repeated)
Secondary outcomes (3)
Working Memory & Executive Function Tasks
CDR Test Battery Memory:
- Numeric Working Memory (Sensitivity (SI); Speed (msec))
- Spatial Working Memory (Sensitivity (SI); Speed (msec))
Measured: 4 times one day (at each test day, tasks 7 times repeated)
Episodic Secondary Memory Tasks
CDR Test Battery Memory:
- Immediate Word Recall (Words correctly recalled (%))
- Delayed Word Recall (Words correctly recalled (%)
- Word Recognition (Sensitivity (SI); Speed (msec))
- Picture Recognition (Sensitivity (SI); Speed (msec))
Measured: 4 times one day (at each test day, tasks 7 times repeated)
Additional Measurements / Questionnaires
- Bond-Lader Visual Analog Scale (VAS) of Mood and Alertness
- Profile of Mood States (POMS) Questionnaire
Measured: 4 times one day (at each test day, VAS 13 times repeated / POMS 3 times repeated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttentionStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kathleen Kelley, MD, Principal investigator, Provident Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143194
- Sponsor's protocol ID
- 2009-11-06-OREG
- Status last verified
- Jun 2011
- First submitted
- 11 Jun 2010
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Effects of Three Doses of the Dietary Supplement oréVida™ on Alertness, Attention and Concentration in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT01143194
- Acronym / sponsor ID
- 2009-11-06-OREG
- Keywords
- Attention, Vigilance, Concentration, Memory, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 14 Jun 2010 (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 purpose of this study is to investigate the effects of the dietary supplement oréVida™ (active ingredient on the basis of a culinary herb)administered twice daily in an acute study on an improvement in vigilance, attention, concentration, memory and mood in 45 healthy men and pre-menopausal women, aged 35-50 years, inclusive.
oréVida™ is considered a dietary supplement, and therefore it is not an approved drug by the Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug Administration does not strictly regulate herbs and dietary supplements. We do not claim that this supplement is meant to treat any ailment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| oréVida™ 60mg/day | Experimental | Dietary Supplement: oréVida™ |
| oréVida™ 120mg/day (1) | Experimental | Dietary Supplement: oréVida™ |
| oréVida™ 120mg/day (2) | Experimental | Dietary Supplement: oréVida™ |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject is a male or pre-menopausal female, 35-50 years, inclusive. Post-menopausal is defined as a history of spontaneous amenorrhea for a period of 12 consecutive months or six weeks post-surgical bilateral oophorectomy, with or without hysterectomy.
- Subject is willing to maintain his or her habitual diet and usual physical activity patterns throughout the study.
- 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 has a body mass index (BMI) of ≥20.00 and <30.00 kg/m2
- Subject is willing to refrain from consuming alcohol 24 h prior to test days.
Key exclusion criteria (17 listed)
- Subject has a positive drug screening of amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, methamphetamines, methadone, 3,4-methylenedioxymethamphetamine, opiates or tricyclic antidepressants at screening.
- Subject has abnormal laboratory test results of clinical significance, including, but not limited to: creatinine ≥1.5 mg/dL, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5X the upper limit of normal at screening.
- Subject has donated more than 300 mL of blood during the three months prior to screening.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the average blood pressure measured at screening. 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 clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorders that, in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.
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 |
|---|---|---|
| oréVida™1 capsule 30 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 60 mg/day) | Dietary supplement | oréVida™ 60mg/day |
| oréVida™1 capsule 60 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 120mg/day) | Dietary supplement | oréVida™ 120mg/day (1) |
| oréVida™1 capsule 120 mg oréVida™ in the morning, one placebo capsule in the afternoon (si in total 120 mg/day) | Dietary supplement | oréVida™ 120mg/day (2) |
| Placebo1 capsule of placebo twice a day | Dietary supplement | Placebo |
Primary outcome
Vigilance, Attention, and Concentration Tasks
Time frame: 4 times one day (at each test day, tasks 13 times repeated)
Cognitive Drug Research (CDR) Test Battery Attention: * Simple Reaction Time (Speed (msec)) * Digit Vigilance (Speed (msec)/ Targets detected (%)) * Choice Reaction Time(Speed (msec))
3 secondary outcomes
Working Memory & Executive Function Tasks
Time frame: 4 times one day (at each test day, tasks 7 times repeated)
Episodic Secondary Memory Tasks
Time frame: 4 times one day (at each test day, tasks 7 times repeated)
Additional Measurements / Questionnaires
Time frame: 4 times one day (at each test day, VAS 13 times repeated / POMS 3 times repeated)
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 2011.
Related trials for Attention
Active, not recruitingObservational study
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
Breast Cancer, Lymphoma
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Active, not recruitingObservational study
A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk
Relapsing Multiple Sclerosis
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
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.
Kathleen Kelley, MD principal investigator
Provident Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oréVida™ in people with Attention and Memory, run by dsm-firmenich Switzerland AG 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 17 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 2011. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Vigilance, Attention, and Concentration Tasks (time frame: 4 times one day (at each test day, tasks 13 times repeated)). 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 9 Jun 2011.