Efficacy of ONE A DAY Weightsmart Advanced Versus Caffeine and Placebo on Energy Expenditure, Thermogenesis and Perceived Energy Levels in Women.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00781586
First received: October 28, 2008
Last updated: November 20, 2013
Last verified: November 2013

October 28, 2008
November 20, 2013
October 2007
April 2008   (final data collection date for primary outcome measure)
  • Area Under the Curve (AUC) of RMR for the first 2 hours [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • AUC of RMR for the last 2 hours [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • AUC of Respiratory Quotient (RQ) for the first 2 hours [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • AUC of RQ for the last 2 hours [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC) of RMR for the first 2 hours [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • AUC of RMR for the last 2 hours [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • AUC of Respiratory Quotient (RQ) for the first 2 hours [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • AUC of RQ for the last 2 hours [ Time Frame: 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00781586 on ClinicalTrials.gov Archive Site
  • Perceived Energy scales - Visual Analog Scale (VAS) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • AUC for heart rate for the first 2 hours [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • AUC for heart rate for the last 2 hours [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Change from baseline for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), respiration and temperature [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Perceived Energy scales - Visual Analog Scale (VAS) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • AUC for heart rate for the first 2 hours [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • AUC for heart rate for the last 2 hours [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Change from baseline for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), respiration and temperature [ Time Frame: 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy of ONE A DAY Weightsmart Advanced Versus Caffeine and Placebo on Energy Expenditure, Thermogenesis and Perceived Energy Levels in Women.
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.

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.

- 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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Energy Expenditure
  • Dietary Supplement: One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350)
    One A Day Weight Smart Advanced 1 tablet at 1st visit
  • Drug: Caffeine
    Caffeine 100 mg 1 tablet at 1st visit
  • Drug: Placebo
    Placebo 1 tablet at 1st visit
  • Experimental: Arm 1
    Intervention: Dietary Supplement: One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350)
  • Active Comparator: Arm 2
    Intervention: Drug: Caffeine
  • Placebo Comparator: Arm 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Female
25 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00781586
12956
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP