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

Bayer

Status and phase

Completed

Phase 4

Conditions

Energy Expenditure

Treatments

Drug: Placebo

Drug: Caffeine

Dietary Supplement: One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00781586

12956

Details and patient eligibility

About

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.

Full 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

Enrollment

22 patients

Sex

Female

Ages

25 to 45 years old

Volunteers

Accepts Healthy Volunteers

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