NCT02542449 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Di Pierro F, Menghi AB, Barreca A, Lucarelli M, Calandrelli A
Greenselect Phytosome as an adjunct to a low-calorie diet for treatment of obesity: a clinical trial. Altern Med Rev. 2009 Jun;14(2):154-60.
Dulloo AG, Duret C, Rohrer D, Girardier L, Mensi N, Fathi M, Chantre P, Vandermander J
Efficacy of a green tea extract rich in catechin polyphenols and caffeine in increasing 24-h energy expenditure and fat oxidation in humans. Am J Clin Nutr. 1999 Dec;70(6):1040-5.
Hursel R, Westerterp-Plantenga MS
Catechin- and caffeine-rich teas for control of body weight in humans. Am J Clin Nutr. 2013 Dec;98(6 Suppl):1682S-1693S. doi: 10.3945/ajcn.113.058396. Epub 2013 Oct 30. Review.
Jurgens TM, Whelan AM, Killian L, Doucette S, Kirk S, Foy E
Green tea for weight loss and weight maintenance in overweight or obese adults. Cochrane Database Syst Rev. 2012 Dec 12;12:CD008650. doi: 10.1002/14651858.CD008650.pub2. Review.
Kovacs EM, Lejeune MP, Nijs I, Westerterp-Plantenga MS
Effects of green tea on weight maintenance after body-weight loss. Br J Nutr. 2004 Mar;91(3):431-7.
Lambert JD, Hong J, Kim DH, Mishin VM, Yang CS
Piperine enhances the bioavailability of the tea polyphenol (-)-epigallocatechin-3-gallate in mice. J Nutr. 2004 Aug;134(8):1948-52.
Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J
Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.
Westerterp-Plantenga MS, Lejeune MP, Kovacs EM
Body weight loss and weight maintenance in relation to habitual caffeine intake and green tea supplementation. Obes Res. 2005 Jul;13(7):1195-204.

Placebo Controlled, Randomized, Single Blinded Trial on the Effects of Greenselect Phytosome® on Weight Maintenance in Obese Women After a 3-month Weight Loss Intervention

Details for clinical trial NCT02542449

Clinical trial NCT02542449 - References