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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.
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.
21 April 2008
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 22 |
| Start date | 2 October 2007 |
| Primary completion | 21 April 2008 |
| Estimated completion | 21 April 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- One-A-Day Weight S.A. (Multi-Vitamins, BAY94-9350)
- Caffeine (caffeine) — full drug profile →
- Placebo
Conditions studied
- Energy Expenditure — all drugs for Energy Expenditure →
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):
-
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 -
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:
- PubMed search for NCT00781586
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Bayer trials
Trials by the same sponsor.
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- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00781586 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 19 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00781586.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing