Status:
COMPLETED
Efficacy of ONE A DAY Weightsmart Advanced Versus Caffeine and Placebo on Energy Expenditure, Thermogenesis and Perceived Energy Levels in Women.
Lead Sponsor:
Bayer
Conditions:
Energy Expenditure
Eligibility:
FEMALE
25-45 years
Phase:
PHASE4
Brief Summary
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 i...
Detailed Description
\- Primary efficacy endpoints are area under the curve (AUC) over the first 2 hours and the last 2 hours of Resting Metabolic RateRespiratory Quotient- The secondary efficacy endpoints are:Perceived E...
Eligibility Criteria
Inclusion
- Be a healthy, ambulatory female between the ages of 25 and 45 years old with a Body Mass Index (BMI) between 20 and 35 kg/m2 (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, brief physical examination, including vital signs, and clinical laboratory tests)
- Consume a habitual caffeine intake (\<300 mg/day or \</= 2 caffeinated drinks/day)
Exclusion
- Pregnant, planning to become pregnant or lactating females
- Using ephedra- or caffeine-containing products or chronic medications other than contraceptives or HRT
- Lost or gained more than five pounds of weight in the preceding three months
- Engage in intense physical activities
- Use of tobacco or nicotine products
- A medical history with known thyroid disease, blood pressure \>140/90 mmHg, diabetes, depression, psychiatric disorders, glaucoma, or seizure disorders and other relevant illnesses that can interfere with the trial in the opinion of the Investigator
Key Trial Info
Start Date :
October 2 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2008
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00781586
Start Date
October 2 2007
End Date
April 21 2008
Last Update
December 19 2018
Active Locations (1)
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1
New York, New York, United States, 10025