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HealthyPhase 1StevReb-PKNCT01403233

Bioavailability of Two Doses of cogniVida™ With One Dose of Rebaudioside A in Healthy Male Subjects

A Phase 1 study testing cogniVida 50mg/day, cogniVida100mg/day and Rebaudioside-A 303.7mg/day in people with Healthy, run by dsm-firmenich Switzerland AG at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to examine the bioavailability of cogniVida™ in 10 healthy male subjects after consumption of two different doses of cogniVida™ (50 mg and 100 mg) and to compare the plasma values with values obtained in subjects receiving rebaudioside A (303.68 mg). Read more about this study

Who is it for?
Ages 30 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
cogniVida 50mg/day, cogniVida100mg/day and Rebaudioside-A 303.7mg/day
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
May 2011to Aug 2011
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 30 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Sex: Male, age 30 - 50 years
  • Subject is willing to maintain his or her habitual diet and physical activity patterns throughout the study period.
  • 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 <28.00 kg/m2 at screening.
  • Subject is willing to refrain from consuming drinks containing grapefruit 7 days prior to test days.
  • Subject is willing to refrain from consuming caffeine, caffeine-containing products and alcoholic drinks 24 h prior to test days and until the end of each assessment period.
  • Subject is willing to refrain from vigorous physical activity 12 h prior to test days.
  • 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.
  • Subjects has a positive blood alcohol and breath carbon monoxide test at screening.
  • Subject has abnormal laboratory test results of clinical significance, including, but not limited to: Epidermal-Growth-Factor-Receptor (eGFR) <60mL/min/1.73m2, 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 or has lost a significant amount of blood during the three months prior to screening.
  • Anemia of any etiology defined as hemoglobin < 140g/L for males and < 123g/L for female
  • Subject has uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the average blood pressure measured at screening.
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  • Subject has a history or presence of cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorders.
  • 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.
  • Subject has a history or presence of cancer in the prior five years, except for non-melanoma skin cancer.
  • Excessive habitual caffeine consumption (>300 mg caffeine/d or ≥ 3 cups of caffeinated coffee/d), following screening and throughout the study period.
  • 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 one month prior to any test 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 (DHA)or a combination of EPA + DHA (≥500 mg/d) within 2 weeks prior to screening.
  • Consumption of stevia extract (reb A / steviosides) sweetened products/drinks or stevia leaves within one month of the study.
  • Subject has had exposure to any non-registered drug product within 30 days prior to the screening visit.
  • Recent history of (within 12 months of screening visit) 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • KGK Synergize Inc

    London, Ontario, N6A 5R8

Other trials in Canada

About this study

Official title: An Open-label, Sequential Supplementation Study Comparing the Bioavailability of Two Doses of cogniVida™ With One Dose of Rebaudioside A in Healthy Male Subjects

The purpose of the study is to examine the bioavailability of cogniVida™ in 10 healthy male subjects after consumption of two different doses of cogniVida™ (50 mg and 100 mg) and to compare the plasma values with values obtained in subjects receiving rebaudioside A (303.68 mg). In addition, also safety and tolerability parameters 24 hours after ingestion of the study compounds will be determined.

cogniVida™ 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. The investigators do not claim that this supplement is meant to treat any ailment.

Conditions
Healthy
Being tested
cogniVida 50mg/day, cogniVida100mg/day, Rebaudioside-A 303.7mg/day
Keywords
Pharmacokinetics, Safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cogniVida 50mg/dayDietary supplement

    2 capsules 25 mg (total 50 mg) cogniVida™ once a day

  • cogniVida100mg/dayDietary supplement

    4 capsules 25 mg (total 100 mg) cogniVida™ once a day

  • Rebaudioside-A 303.7mg/dayDietary supplement

    4 capsules 75.92 mg (total 303.68 mg) rebaudioside A once a day

Study groups in NCT01403233
Study groupRoleWhat they receive
cogniVida™ 50 mg/dayExperimentalNot described
Receives: Dietary Supplement: cogniVida 50mg/day
cogniVida™ 100 mg/dayExperimentalNot described
Receives: Dietary Supplement: cogniVida100mg/day
Rebaudioside-A 303.7 mg/dayActive comparatorNot described
Receives: Dietary Supplement: Rebaudioside-A 303.7mg/day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma Area under the Curve (AUC) (0-72 hours) being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption

    Blood sampling timepoints: cogniVida: 0 min, 15min, 30min, 45min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 48, and 72h after dosing.

    RebA: 0 min, 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36, 48, and 72h after dosing

    Measured: 0 - 72 hours

Secondary outcomes (8)

  1. Time to plasma peak (Tmax) being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption

    Blood sampling timepoints: cogniVida: 0 min, 15min, 30min, 45min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 48, and 72h after dosing.

    RebA: 0 min, 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36, 48, and 72h after dosing

    Measured: 0 - 72 hours

  2. Plasma Peak Concentration (Cmax) being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption

    Blood sampling timepoints: cogniVida: 0 min, 15min, 30min, 45min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 48, and 72h after dosing.

    RebA: 0 min, 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36, 48, and 72h after dosing

    Measured: 0 - 72 hours

  3. Time to reach half of peak concentration in plasma T1/2 being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption

    Blood sampling timepoints: cogniVida: 0 min, 15min, 30min, 45min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 48, and 72h after dosing.

    RebA: 0 min, 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36, 48, and 72h after dosing

    Measured: 0 - 72 hours

  4. Vital signs

    Vital signs as safety parameters being measured 24 h after each supplementation.

    Measured: 24 hours after each supplementation

  5. White blood cell (WBC) count (Routine Haematology)

    White blood cells will be counted as a routine haematology parameter to assess safety 24 h after each supplementation.

    Measured: 24 hours after each supplementation

  6. Hemoglobin (Routine Haematology)

    Hemoglobin will be measured as a routine haematology parameter to assess safety 24 h after each supplementation.

    Measured: 24 hours after each supplementation

  7. Blood urea nitrogen (BUN) (Clinical Chemistry)

    Blood urea nitrogen will be measured as a routine clinical chemistry parameter to assess safety 24 h after each supplementation.

    Measured: 24 hours after each supplementation

  8. Cystatin-C (Clinical Chemistry)

    Cystatin-C will be measured as a routine clinical chemistry parameter to assess safety 24 h after each supplementation.

    Measured: 24 hours after each supplementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01403233
Sponsor's protocol ID
2010-06-01-STEV
Acronym
StevReb-PK
Status last verified
Jun 2012
First submitted
19 Jul 2011
Last updated
14 Jun 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cogniVida 50mg/day, cogniVida100mg/day and Rebaudioside-A 303.7mg/day in people with Healthy, run by dsm-firmenich Switzerland AG at 1 site in Canada.

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 8 inclusion and 16 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 14 Jun 2012. 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 Canada. 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. 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?

Plasma Area under the Curve (AUC) (0-72 hours) being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption (time frame: 0 - 72 hours). 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 NCT01403233.

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 14 Jun 2012.

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