check_circleStudy Completed

Energy expenditure

Bayer Identifier:

12956

ClinicalTrials.gov Identifier:

NCT00781586

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy of ONE A DAY weightsmart advanced versus caffeine and placebo on energy expenditure, thermogenesis and perceived energy levels in women.

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.

Key Participants Requirements

Sex

Female

Age

25 - 45 Years
  • - 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
  • - 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
22
Trial Dates
October 2007 - April 2008
Phase
Phase 4
Could I Receive a placebo
Yes
Products
One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
New York, 10025, United States

Primary Outcome

  • Area Under the Curve (AUC) of RMR for the first 2 hours
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    no
  • AUC of RMR for the last 2 hours
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • AUC of Respiratory Quotient (RQ) for the first 2 hours
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • AUC of RQ for the last 2 hours
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Perceived Energy scales - Visual Analog Scale (VAS)
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    no
  • AUC for heart rate for the first 2 hours
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • AUC for heart rate for the last 2 hours
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), respiration and temperature
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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