Efficacy of ONE A DAY weightsmart advanced versus caffeine and placebo on energy expenditure, thermogenesis and perceived energy levels in women.
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.
- 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)
- 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
New York, United States, 10025
E-mail: [email protected]
Phone: Not Available
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.