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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:
Bayer
ClinicalTrials.gov Identifier:
NCT00781586
First received: October 28, 2008
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  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
 Dietary Supplement: One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350)
Drug: Caffeine
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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:
  • 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
Experimental: Arm 1 Dietary Supplement: One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350)
One A Day Weight Smart Advanced 1 tablet at 1st visit
Active Comparator: Arm 2 Drug: Caffeine
Caffeine 100 mg 1 tablet at 1st visit
Placebo Comparator: Arm 3 Drug: Placebo
Placebo 1 tablet at 1st 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 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

  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
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical and Medical Affairs, Bayer Healthcare LLC, ConsumerCare
ClinicalTrials.gov Identifier: NCT00781586     History of Changes
Other Study ID Numbers: 12956
Study First Received: October 28, 2008
Last Updated: November 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Energy expenditure
Nutritional
Weight control

Additional relevant MeSH terms:
Caffeine
Vitamins
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013