Trial Condition(s):

Energy expenditure

Efficacy of ONE A DAY weightsmart advanced versus caffeine and placebo on energy expenditure, thermogenesis and perceived energy levels in women.

Bayer Identifier:

12956

ClinicalTrials.gov Identifier:

NCT00781586

EudraCT Number:

Not Available

Study Completed

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.

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

Trial Summary

Enrollment Goal
22
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
Yes
Products
One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

New York, United States, 10025

Status
Completed
 

Trial Design