Trial Condition(s):
Energy expenditure
Efficacy of ONE A DAY weightsmart advanced versus caffeine and placebo on energy expenditure, thermogenesis and perceived energy levels in women.
Bayer Identifier:
12956
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site New York, United States, 10025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Primary Outcome
- Area Under the Curve (AUC) of RMR for the first 2 hoursTimeframe: 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 hoursTimeframe: 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 hoursTimeframe: 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 RQ for the last 2 hoursTimeframe: 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 Outcome
- Perceived Energy scales - Visual Analog Scale (VAS)Timeframe: 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 hoursTimeframe: 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 hoursTimeframe: 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 temperatureTimeframe: 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
Additional Information
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