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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00781586
Other study ID # 12956
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2, 2007
Est. completion date April 21, 2008

Study information

Verified date December 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date April 21, 2008
Est. primary completion date April 21, 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
Placebo
Placebo 1 tablet at 1st visit

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Curve (AUC) of RMR for the first 2 hours 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
Primary AUC of RMR for the last 2 hours 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
Primary AUC of Respiratory Quotient (RQ) for the first 2 hours 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
Primary AUC of RQ for the last 2 hours 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 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
Secondary AUC for heart rate for the first 2 hours 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
Secondary AUC for heart rate for the last 2 hours 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
Secondary Change from baseline for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), respiration and temperature 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
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