Efficacy of ONE A DAY Weightsmart Advanced Versus Caffeine and Placebo on Energy Expenditure, Thermogenesis and Perceived Energy Levels in Women.
Completed · Phase 4 · Has a placebo group
Conditions studied: Energy Expenditure
In brief
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.
Key facts
- Study ID
- NCT00781586
- Run by
- Bayer
- People needed
- 22
- Starts
- 2007-10-02
- Expected to finish
- 2008-04-21
- Last updated by the study team
- 2018-12-19
Who can join
Age: 25 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Study site — New York, New York, United States
Full record on ClinicalTrials.gov
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