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NCT00781586

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

Completed Phase 4 Last updated 19 December 2018
What this trial tests

Phase 4 trial testing One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350) in Energy Expenditure in 22 participants. Completed in 21 April 2008.

Timeline
2 October 2007
Primary endpoint
21 April 2008
21 April 2008

Quick facts

Lead sponsorBayer
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposeprevention
Enrollment22
Start date2 October 2007
Primary completion21 April 2008
Estimated completion21 April 2008
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

Adults 25 to 45, female only, with Energy Expenditure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Small molecules for fat combustion: targeting obesity.
    Liu J, Wang Y, Lin L. · · 2019 · cited 91× · PMID 30976490 · DOI 10.1016/j.apsb.2018.09.007
  2. Clinical Application Potential of Small Molecules that Induce Brown Adipose Tissue Thermogenesis by Improving Fat Metabolism.
    Lu KY, Primus Dass KT, Tsai SF, Chuang HM, et al · · 2020 · cited 2× · PMID 32854518 · DOI 10.1177/0963689720927394

Verify or expand the search:

Other recruiting trials for Energy Expenditure

Currently open trials in the same condition.

Other Bayer trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing