Trial Condition(s):
Efficacy of ONE A DAY weightsmart advanced versus caffeine and placebo on energy expenditure, thermogenesis and perceived energy levels in women.
12956
Not Available
Not Available
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
Locations | |
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Locations Investigative Site New York, United States, 10025 | Contact Us: 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.
Trial Type:
Interventional
Intervention Type:
Dietary Supplement
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Crossover Assignment
Trial Arms:
3