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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00781586

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.

Condition	Intervention	Phase
Energy Expenditure	Drug: BAY 94-9350 Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Caffeine

Drug Information available for: 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Caffeine citrate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

The primary efficacy endpoints are : 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 ]

Secondary Outcome Measures:

The secondary efficacy endpoints are: 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 ]

Enrollment:	21
Study Start Date:	October 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: BAY 94-9350 One A Day Weight Smart Advanced 1 tablet at 1 visit Caffeine 100 mg 1 tablet at 1 visit
Arm 2: Placebo Comparator	Drug: Placebo Placebo 1 tablet at 1 visit

Detailed Description:

Primary efficacy endpoints are area under the curve (AUC) over the first 2 hours and the last 2 hours of

Resting Metabolic Rate Respiratory 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

Eligibility

Ages Eligible for Study:	25 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781586

Locations

United States, New York

New York, New York, United States, 10019

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer ConsumerCare Inc. ( Therapeutic Area Head )
Study ID Numbers:	12956
Study First Received:	October 28, 2008
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00781586 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Energy expenditure
Nutritional
Weight control

Study placed in the following topic categories:

Caffeine citrate
Body Weight
Phosphodiesterase Inhibitors
Central Nervous System Stimulants
Caffeine

Additional relevant MeSH terms:

Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Stimulants

Enzyme Inhibitors
Caffeine
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2009