Behall KM, Scholfield DJ, Hallfrisch J Diets containing barley significantly reduce lipids in mildly hypercholesterolemic men and women. Am J Clin Nutr. 2004 Nov;80(5):1185-93.
Behall KM, Scholfield DJ, Hallfrisch J Whole-grain diets reduce blood pressure in mildly hypercholesterolemic men and women. J Am Diet Assoc. 2006 Sep;106(9):1445-9.
Dolin BJ Effects of a proprietary Bacillus coagulans preparation on symptoms of diarrhea-predominant irritable bowel syndrome. Methods Find Exp Clin Pharmacol. 2009 Dec;31(10):655-9. doi: 10.1358/mf.2009.31.10.1441078.
Emerick RE The politics of psychiatric self-help: political factions, interactional support, and group longevity in a social movement. Soc Sci Med. 1991;32(10):1121-8.
Endres JR, Clewell A, Jade KA, Farber T, Hauswirth J, Schauss AG Safety assessment of a proprietary preparation of a novel Probiotic, Bacillus coagulans, as a food ingredient. Food Chem Toxicol. 2009 Jun;47(6):1231-8. doi: 10.1016/j.fct.2009.02.018. Epub 2009 Feb 25.
Endres JR, Qureshi I, Farber T, Hauswirth J, Hirka G, Pasics I, Schauss AG One-year chronic oral toxicity with combined reproduction toxicity study of a novel probiotic, Bacillus coagulans, as a food ingredient. Food Chem Toxicol. 2011 May;49(5):1174-82. doi: 10.1016/j.fct.2011.02.012. Epub 2011 Feb 19.
Honda H, Gibson GR, Farmer S, Keller D, McCartney AL Use of a continuous culture fermentation system to investigate the effect of GanedenBC30 (Bacillus coagulans GBI-30, 6086) supplementation on pathogen survival in the human gut microbiota. Anaerobe. 2011 Feb;17(1):36-42. doi: 10.1016/j.anaerobe.2010.12.006. Epub 2010 Dec 30.
Hun L Bacillus coagulans significantly improved abdominal pain and bloating in patients with IBS. Postgrad Med. 2009 Mar;121(2):119-24. doi: 10.3810/pgm.2009.03.1984.
Kalman DS, Schwartz HI, Alvarez P, Feldman S, Pezzullo JC, Krieger DR A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms. BMC Gastroenterol. 2009 Nov 18;9:85. doi: 10.1186/1471-230X-9-85.
Kimmel M, Keller D, Farmer S, Warrino DE A controlled clinical trial to evaluate the effect of GanedenBC(30) on immunological markers. Methods Find Exp Clin Pharmacol. 2010 Mar;32(2):129-32. doi: 10.1358/mf.2010.32.2.1423881.
Lappi J, Kolehmainen M, Mykkänen H, Poutanen K Do large intestinal events explain the protective effects of whole grain foods against type 2 diabetes? Crit Rev Food Sci Nutr. 2013;53(6):631-40. doi: 10.1080/10408398.2010.550388. Review.
Lappi J, Salojärvi J, Kolehmainen M, Mykkänen H, Poutanen K, de Vos WM, Salonen A Intake of whole-grain and fiber-rich rye bread versus refined wheat bread does not differentiate intestinal microbiota composition in Finnish adults with metabolic syndrome. J Nutr. 2013 May;143(5):648-55. doi: 10.3945/jn.112.172668. Epub 2013 Mar 20.
Leinonen KS, Poutanen KS, Mykkänen HM Rye bread decreases serum total and LDL cholesterol in men with moderately elevated serum cholesterol. J Nutr. 2000 Feb;130(2):164-70.
Mandel DR, Eichas K, Holmes J Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial. BMC Complement Altern Med. 2010 Jan 12;10:1. doi: 10.1186/1472-6882-10-1.
McIntosh GH, Noakes M, Royle PJ, Foster PR Whole-grain rye and wheat foods and markers of bowel health in overweight middle-aged men. Am J Clin Nutr. 2003 Apr;77(4):967-74.
Nilsson AC, Ostman EM, Holst JJ, Björck IM Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J Nutr. 2008 Apr;138(4):732-9.
Pellegrini N, Del Rio D, Colombi B, Bianchi M, Brighenti F Application of the 2,2'-azinobis(3-ethylbenzothiazoline-6-sulfonic acid) radical cation assay to a flow injection system for the evaluation of antioxidant activity of some pure compounds and beverages. J Agric Food Chem. 2003 Jan 1;51(1):260-4.
Priebe MG, Wang H, Weening D, Schepers M, Preston T, Vonk RJ Factors related to colonic fermentation of nondigestible carbohydrates of a previous evening meal increase tissue glucose uptake and moderate glucose-associated inflammation. Am J Clin Nutr. 2010 Jan;91(1):90-7. doi: 10.3945/ajcn.2009.28521. Epub 2009 Nov 4.
Scazzina F, Siebenhandl-Ehn S, Pellegrini N The effect of dietary fibre on reducing the glycaemic index of bread. Br J Nutr. 2013 Apr 14;109(7):1163-74. doi: 10.1017/S0007114513000032. Epub 2013 Feb 18. Review.
Ye EQ, Chacko SA, Chou EL, Kugizaki M, Liu S Greater whole-grain intake is associated with lower risk of type 2 diabetes, cardiovascular disease, and weight gain. J Nutr. 2012 Jul;142(7):1304-13. doi: 10.3945/jn.111.155325. Epub 2012 May 30. Review. Erratum in: J Nutr. 2013 Sep;143(9):1524.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.