Energy Expenditure Clinical Trial
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.
Verified date | December 2018 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | April 21, 2008 |
Est. primary completion date | April 21, 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Curve (AUC) of RMR for the first 2 hours | Primary efficacy endpoints are area under the curve (AUC) over the first 2 hours and the last 2 hours of Resting Metabolic Rate and Respiratory Quotient | ||
Primary | AUC of RMR for the last 2 hours | Primary efficacy endpoints are area under the curve (AUC) over the first 2 hours and the last 2 hours of Resting Metabolic Rate and Respiratory Quotient | ||
Primary | AUC of Respiratory Quotient (RQ) for the first 2 hours | Primary efficacy endpoints are area under the curve (AUC) over the first 2 hours and the last 2 hours of Resting Metabolic Rate and Respiratory Quotient | ||
Primary | AUC of RQ for the last 2 hours | Primary efficacy endpoints are area under the curve (AUC) over the first 2 hours and the last 2 hours of Resting Metabolic Rate and Respiratory Quotient | ||
Secondary | 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 | ||
Secondary | AUC for heart rate for the first 2 hours | 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 | ||
Secondary | AUC for heart rate for the last 2 hours | 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 | ||
Secondary | Change from baseline for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), respiration and temperature | 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 |
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