NCT00781586

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Energy Expenditure

Interventions

Type	Name	Description
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
DRUG	Placebo	Placebo 1 tablet at 1st visit

Timeline

• Start date: 2007-10-02
• Primary completion: 2008-04-21
• Completion: 2008-04-21
• First posted: 2008-10-29
• Last updated: 2018-12-19

Locations

1 site across 1 country: United States