ClinicalTrials.gg
CompletedNCT01403233StevReb-PKUpdated Jun 14, 2012

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

A Phase 1 interventional study of cogniVida 50mg/day and cogniVida100mg/day in Healthy, sponsored by dsm-firmenich Switzerland AG. Completed at 1 site in Canada. Open to male participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-14.

Sponsored by dsm-firmenich Switzerland AG (part of dsm-firmenich) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
30 Years to 50 Years
Sex
Male
01

Study 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). 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.

02

Conditions studied

  • Healthy

Keywords

  • Pharmacokinetics
  • Safety
03

In context

Lead sponsor

dsm-firmenich Switzerland AG is the lead sponsor of 9 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    cogniVida™ 50 mg/day

    Dietary Supplement: cogniVida 50mg/day

  • Experimental
    cogniVida™ 100 mg/day

    Dietary Supplement: cogniVida100mg/day

  • Active comparator
    Rebaudioside-A 303.7 mg/day

    Dietary Supplement: Rebaudioside-A 303.7mg/day

Interventions

  • Dietary supplementcogniVida 50mg/day

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

  • Dietary supplementcogniVida100mg/day

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

  • Dietary supplementRebaudioside-A 303.7mg/day

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

06

What researchers measure

Primary outcomes

  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

    Time frame: 0 - 72 hours

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 0 - 72 hours

  4. Vital signs

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 24 hours after each supplementation

07

Study locations

1 site
  • KGK Synergize Inc
    London, Ontario N6A 5R8, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2011, a primary completion of Aug 2011 and a completion of Aug 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2011
First posted
Jul 27, 2011
Start
May 2011
Primary completionActual
Aug 2011
CompletionActual
Aug 2011
Last update
Jun 14, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01403233
Responsible party
Sponsor
First posted
Jul 27, 2011
Start date
May 2011
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Jun 14, 2012

Study contacts

Dale Wilson, MD
principal investigator · KGK Science Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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