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Trial record 86 of 730 for:    Area Under Curve AND Bioavailability

Bioavailability of Two Doses of cogniVida™ With One Dose of Rebaudioside A in Healthy Male Subjects (StevReb-PK)

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ClinicalTrials.gov Identifier: NCT01403233
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.

Tracking Information
First Submitted Date  ICMJE July 19, 2011
First Posted Date  ICMJE July 27, 2011
Last Update Posted Date June 14, 2012
Study Start Date  ICMJE May 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2011)
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 ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
Plasma AUC (0-72 hours) being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption [ Time Frame: 0 - 72 hours ]
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
Change History Complete list of historical versions of study NCT01403233 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2011)
  • Time to plasma peak (Tmax) being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption [ Time Frame: 0 - 72 hours ]
    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
  • Plasma Peak Concentration (Cmax) being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption [ Time Frame: 0 - 72 hours ]
    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 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 [ Time Frame: 0 - 72 hours ]
    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
  • Vital signs [ Time Frame: 24 hours after each supplementation ]
    Vital signs as safety parameters being measured 24 h after each supplementation.
  • White blood cell (WBC) count (Routine Haematology) [ Time Frame: 24 hours after each supplementation ]
    White blood cells will be counted as a routine haematology parameter to assess safety 24 h after each supplementation.
  • Hemoglobin (Routine Haematology) [ Time Frame: 24 hours after each supplementation ]
    Hemoglobin will be measured as a routine haematology parameter to assess safety 24 h after each supplementation.
  • Blood urea nitrogen (BUN) (Clinical Chemistry) [ Time Frame: 24 hours after each supplementation ]
    Blood urea nitrogen will be measured as a routine clinical chemistry parameter to assess safety 24 h after each supplementation.
  • Cystatin-C (Clinical Chemistry) [ Time Frame: 24 hours after each supplementation ]
    Cystatin-C will be measured as a routine clinical chemistry parameter to assess safety 24 h after each supplementation.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
  • Plasma Tmax being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption [ Time Frame: 0 - 72 hours ]
    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
  • Plasma Cmax being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption [ Time Frame: 0 - 72 hours ]
    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
  • Plasma T1/2 being produced after cogniVida™ (50 and 100 mg) and rebaudioside A (303.68 mg) consumption [ Time Frame: 0 - 72 hours ]
    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
  • Vital signs [ Time Frame: 24 hours after each supplementation ]
    Vital signs as safety parameters being measured 24 h after each supplementation.
  • White blood cell (WBC) count (Routine Haematology) [ Time Frame: 24 hours after each supplementation ]
    White blood cells will be counted as a routine haematology parameter to assess safety 24 h after each supplementation.
  • Hemoglobin (Routine Haematology) [ Time Frame: 24 hours after each supplementation ]
    Hemoglobin will be measured as a routine haematology parameter to assess safety 24 h after each supplementation.
  • Blood urea nitrogen (BUN) (Clinical Chemistry) [ Time Frame: 24 hours after each supplementation ]
    Blood urea nitrogen will be measured as a routine clinical chemistry parameter to assess safety 24 h after each supplementation.
  • Cystatin-C (Clinical Chemistry) [ Time Frame: 24 hours after each supplementation ]
    Cystatin-C will be measured as a routine clinical chemistry parameter to assess safety 24 h after each supplementation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability of Two Doses of cogniVida™ With One Dose of Rebaudioside A in Healthy Male Subjects
Official Title  ICMJE An Open-label, Sequential Supplementation Study Comparing the Bioavailability of Two Doses of cogniVida™ With One Dose of Rebaudioside A in Healthy Male Subjects
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: cogniVida 50mg/day
    2 capsules 25 mg (total 50 mg) cogniVida™ once a day
  • Dietary Supplement: cogniVida100mg/day
    4 capsules 25 mg (total 100 mg) cogniVida™ once a day
  • Dietary Supplement: Rebaudioside-A 303.7mg/day
    4 capsules 75.92 mg (total 303.68 mg) rebaudioside A once a day
Study Arms  ICMJE
  • Experimental: cogniVida™ 50 mg/day
    Intervention: Dietary Supplement: cogniVida 50mg/day
  • Experimental: cogniVida™ 100 mg/day
    Intervention: Dietary Supplement: cogniVida100mg/day
  • Active Comparator: Rebaudioside-A 303.7 mg/day
    Intervention: Dietary Supplement: Rebaudioside-A 303.7mg/day
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2011)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01403233
Other Study ID Numbers  ICMJE 2010-06-01-STEV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DSM Nutritional Products, Inc.
Study Sponsor  ICMJE DSM Nutritional Products, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dale Wilson, MD KGK Science Inc.
PRS Account DSM Nutritional Products, Inc.
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP