- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00781586
Efficacy of ONE A DAY Weightsmart Advanced Versus Caffeine and Placebo on Energy Expenditure, Thermogenesis and Perceived Energy Levels in Women.
December 17, 2018 updated by: Bayer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10025
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm 1
|
One A Day Weight Smart Advanced 1 tablet at 1st visit
|
ACTIVE_COMPARATOR: Arm 2
|
Caffeine 100 mg 1 tablet at 1st visit
|
PLACEBO_COMPARATOR: Arm 3
|
Placebo 1 tablet at 1st visit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 2, 2007
Primary Completion (ACTUAL)
April 21, 2008
Study Completion (ACTUAL)
April 21, 2008
Study Registration Dates
First Submitted
October 28, 2008
First Submitted That Met QC Criteria
October 28, 2008
First Posted (ESTIMATE)
October 29, 2008
Study Record Updates
Last Update Posted (ACTUAL)
December 19, 2018
Last Update Submitted That Met QC Criteria
December 17, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12956
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Energy Expenditure
-
Hospices Civils de LyonCompleted
-
University of South CarolinaCompleted
-
Pennington Biomedical Research CenterCompletedEnergy ExpenditureUnited States
-
American University of Beirut Medical CenterUnknownEnergy ExpenditureLebanon
-
Catholic University of BrasíliaCompletedEnergy Expenditure
-
Clinical Nutrition Research Centre, SingaporeCompletedEnergy ExpenditureSingapore
-
Institut National de Recherche pour l'Agriculture...Centre de Recherche en Nutrition Humaine Rhone-Alpe; Centre de Recherche en...CompletedEnergy Expenditure | Computer Simulation | Energy MetabolismFrance
-
University of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrolling by invitation
-
University of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of ThessalyCompleted
Clinical Trials on One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350)
-
The Cooper InstituteCooper ClinicCompleted
-
Fujian Cancer HospitalNot yet recruiting
-
Johns Hopkins Bloomberg School of Public HealthJohns Hopkins University; United States Agency for International Development... and other collaboratorsCompletedPreterm Birth | Low Birth Weight | Infant Mortality | Perinatal Mortality | Neonatal MortalityUnited States, Bangladesh
-
Patrick RobinsonRecruitingCovid19 | COVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Acute BronchitisUnited States
-
Children's Hospital Medical Center, CincinnatiCompleted
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Acute Lymphoblastic Leukemia | Acute Leukemia | Myelodysplastic SyndromeUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityTerminatedPrimary Myelofibrosis | Anemia | Recurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Anatomic Stage IV Breast Cancer AJCC v8 | Recurrent Acute Myeloid Leukemia | Recurrent Myelodysplastic Syndrome | Refractory Acute Myeloid Leukemia | Refractory Chronic Myelomonocytic Leukemia | Refractory Myelodysplastic... and other conditionsUnited States