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

NCT00781586 | Completed Phase 4

• 1 other identifier: 12956
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Energy Expenditure

Keywords

Energy expenditure; Nutritional; Weight control

Outcome Measures

Primary Outcomes (4)

• Area Under the Curve (AUC) of RMR for the first 2 hours

  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

• AUC of RMR for the last 2 hours

  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

• AUC of Respiratory Quotient (RQ) for the first 2 hours

  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

• AUC of RQ for the last 2 hours

  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 (4)

• 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

• AUC for heart rate for the first 2 hours

  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

• AUC for heart rate for the last 2 hours

  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

• Change from baseline for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), respiration and temperature

  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

Study Arms (3)

Arm 1

EXPERIMENTAL

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

Arm 2

ACTIVE COMPARATOR

Drug: Caffeine

Arm 3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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

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

Arm 1

Caffeine DRUG

Caffeine 100 mg 1 tablet at 1st visit

Arm 2

Placebo DRUG

Placebo 1 tablet at 1st visit

Arm 3

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

New York, New York, 10025, United States

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: October 2, 2007
• Primary Completion: April 21, 2008
• Study Completion: April 21, 2008
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

US (1)