Energy Expenditure
Conditions
Keywords
Energy expenditure, Nutritional, Weight control
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 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.
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 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
Interventions
DIETARY_SUPPLEMENTOne-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350)
One A Day Weight Smart Advanced 1 tablet at 1st visit
DRUGCaffeine
Caffeine 100 mg 1 tablet at 1st visit
DRUGPlacebo
Placebo 1 tablet at 1st visit
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed