NCT02644109 - 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)

Korpela R, Tuomilehto J, Högström P, Seppo L, Piironen V, Salo-Väänänen P, Toivo J, Lamberg-Allardt C, Kärkkäinen M, Outila T, Sundvall J, Vilkkilä S, Tikkanen MJ
Safety aspects and cholesterol-lowering efficacy of low fat dairy products containing plant
Mannarino E, Pirro M, Cortese C, Lupattelli G, Siepi D, Mezzetti A, Bertolini S, Parillo M, Fellin R, Pujia A, Averna M, Nicolle C, Notarbartolo A
Effects of a phytosterol-enriched dairy product on lipids, sterols and 8-isoprostane in hypercholesterolemi
Miettinen TA, Puska P, Gylling H, Vanhanen H, Vartiainen E
Reduction of serum cholesterol with sitostanol-ester margarine in a mildly hypercholesterolemic population. N Engl J Med. 1995 Nov 16;333(20):1308-12.
Nestel P, Cehun M, Pomeroy S, Abbey M, Weldon G
Cholesterol-lowering effects of plant sterol esters and non-esterified stanols in margarine, butter and low-fat foods. Eur J Clin Nutr. 2001 Dec;55(12):1084-90.
Ortega RM, Palencia A, López-Sobaler AM
Improvement of cholesterol levels and reduction of cardiovascular risk via the consumption of phytosterols. Br J Nutr. 2006 Aug;96 Suppl 1:S89-93.
Stone NJ, Robinson JG, Lichtenstein AH, Goff DC Jr, Lloyd-Jones DM, Smith SC Jr, Blum C, Schwartz JS; 2013 ACC/AHA Cholesterol Guideline Panel
Treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk in adults: synopsis of the 2013 American College of Cardiology/American Heart Association cholesterol guideline. Ann Intern Med. 2014 Mar 4;160(5):339-43. doi: 10.7326/M14-0126.

Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols In Chilean Subjects With Hypercholesterolemia

Details for clinical trial NCT02644109

Clinical trial NCT02644109 - References