NCT01248286 - 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)

Fung TT, Hu FB, Pereira MA, Liu S, Stampfer MJ, Colditz GA, Willett WC
Whole-grain intake and the risk of type 2 diabetes: a prospective study in men. Am J Clin Nutr. 2002 Sep;76(3):535-40.
Liese AD, Roach AK, Sparks KC, Marquart L, D'Agostino RB Jr, Mayer-Davis EJ
Whole-grain intake and insulin sensitivity: the Insulin Resistance Atherosclerosis Study. Am J Clin Nutr. 2003 Nov;78(5):965-71.
McKeown NM, Meigs JB, Liu S, Wilson PW, Jacques PF
Whole-grain intake is favorably associated with metabolic risk factors for type 2 diabetes and cardiovascular disease in the Framingham Offspring Study. Am J Clin Nutr. 2002 Aug;76(2):390-8.
Montonen J, Knekt P, Järvinen R, Aromaa A, Reunanen A
Whole-grain and fiber intake and the incidence of type 2 diabetes. Am J Clin Nutr. 2003 Mar;77(3):622-9.
Steffen LM, Jacobs DR Jr, Murtaugh MA, Moran A, Steinberger J, Hong CP, Sinaiko AR
Whole grain intake is associated with lower body mass and greater insulin sensitivity among adolescents. Am J Epidemiol. 2003 Aug 1;158(3):243-50.

Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes

Clinical trial NCT01248286 - References