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

NCT ID: NCT00781586

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-02

Study Completion Date

2008-04-21

Brief Summary

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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

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\- 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

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Energy Expenditure

Keywords

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Energy expenditure Nutritional Weight control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

Arm 2

Group Type ACTIVE_COMPARATOR

Caffeine

Intervention Type DRUG

Caffeine 100 mg 1 tablet at 1st visit

Arm 3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 1 tablet at 1st visit

Interventions

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

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

Intervention Type DIETARY_SUPPLEMENT

Caffeine

Caffeine 100 mg 1 tablet at 1st visit

Intervention Type DRUG

Placebo

Placebo 1 tablet at 1st visit

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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12956

Identifier Type: -

Identifier Source: org_study_id