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Bioavailability of Two Doses of cogniVidaâ„¢ With One Dose of Rebaudioside A in Healthy Male Subjects

NCT01403233 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-06-14

No results posted yet for this study

Summary

The purpose of the study is to examine the bioavailability of cogniVidaâ„¢ in 10 healthy male subjects after consumption of two different doses of cogniVidaâ„¢ (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.

cogniVidaâ„¢ 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

Interventions

DIETARY_SUPPLEMENT

cogniVida 50mg/day

2 capsules 25 mg (total 50 mg) cogniVidaâ„¢ once a day

DIETARY_SUPPLEMENT

cogniVida100mg/day

4 capsules 25 mg (total 100 mg) cogniVidaâ„¢ once a day

DIETARY_SUPPLEMENT

Rebaudioside-A 303.7mg/day

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

Sponsors & Collaborators

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Dale Wilson, MD · KGK Science Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01403233 on ClinicalTrials.gov