Skip to main content
OpenTrials
Completed

NCT Number: NCT00781586

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Energy Expenditure

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

New York, 10025, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

One A Day Weight Smart Advanced 1 tablet at 1st visit

Caffeine

Drug

Caffeine 100 mg 1 tablet at 1st visit

Placebo

Drug

Placebo 1 tablet at 1st visit

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 29, 2008
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.