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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00781586 |
The study is considered research because efficacy (how well a drug works) information is needed in healthy, 25-45 year-old, female subjects with moderate caffeine intake. The investigational product is available in the United States without a prescription (over-the-counter) as a nutritional supplement.
The purpose of this study is to assess whether One-A-Day Weightsmart Advanced is safe and can increase metabolism and perceived energy in female subjects compared with caffeine or placebo (inactive drug). Participation in this study will last approximately 4 weeks and require about 4 outpatient visits to St. Luk's-Roosevelt Hospital Center. About 21 subjects are expected to participate in this study.
Condition | Intervention | Phase |
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Energy Expenditure |
Drug: BAY 94-9350 Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Single Center, Double-Blind, Three-Way Crossover Trial to Evaluate the Efficacy of ONE A DAY Weightsmart Advanced Versus Caffeine and Placebo on Energy Expenditure, Thermogenesis and Perceived Energy Levels in Women |
Enrollment: | 21 |
Study Start Date: | October 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Active Comparator |
Drug: BAY 94-9350
One A Day Weight Smart Advanced 1 tablet at 1 visit Caffeine 100 mg 1 tablet at 1 visit
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Arm 2: Placebo Comparator |
Drug: Placebo
Placebo 1 tablet at 1 visit
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Perceived Energy scales Visual Analog Scale (VAS) Change from baseline for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) respiration, average heart rate over 1st 20 minutes, average heart rate over last 20 minutes, and temperature
Ages Eligible for Study: | 25 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bayer ConsumerCare Inc. ( Therapeutic Area Head ) |
Study ID Numbers: | 12956 |
Study First Received: | October 28, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00781586 History of Changes |
Health Authority: | United States: Institutional Review Board |
Energy expenditure Nutritional Weight control |
Caffeine citrate Body Weight Phosphodiesterase Inhibitors Central Nervous System Stimulants Caffeine |
Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs Central Nervous System Stimulants |
Enzyme Inhibitors Caffeine Central Nervous System Agents Pharmacologic Actions |