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NCT00781586 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Energy Expenditure, sponsored by Bayer.

Completed
Registry status
Phase 4
Development phase
22
Enrollment target
1
Study location

NCT00781586: Completed Phase 4 study of Energy Expenditure, sponsored by Bayer.

NCT00781586 is a Phase 4 study of Energy Expenditure that has completed, run by Bayer. The registered enrollment target is 22 participants, below the 91-participant average among 6 other Energy Expenditure trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00781586, a Phase 4 study of Energy Expenditure, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 4
Development phase
22 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DRUG Placebo
  • DRUG Caffeine
  • DIETARY_SUPPLEMENT One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350)

Study Locations (1)

New York

  • - New York

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2007-10-02
Est. Completion 2008-04-21
Phase Phase 4
Bayer

591 total trials

What the finished NCT00781586 record still lists

NCT00781586 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 91-participant average among 6 other Energy Expenditure trials with a reported enrollment target (76% lower).

The record links to 1 condition, with Energy Expenditure appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00781586 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT00781586 about?

NCT00781586 is a clinical study titled "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 suppleme...

What is the current status of trial NCT00781586?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2007-10-02. Estimated completion is 2008-04-21.

What conditions does trial NCT00781586 study?

This clinical trial studies the following conditions: Energy Expenditure.

What interventions are being tested in trial NCT00781586?

The interventions under investigation include: Placebo (DRUG), Caffeine (DRUG), One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350) (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00781586?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00781586 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00781586, the US trial registry maintained by the National Library of Medicine. NCT00781586 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.