Corbalan-Tutau D, Madrid JA, Nicolas F, Garaulet M Daily profile in two circadian markers "melatonin and cortisol" and associations with metabolic syndrome components. Physiol Behav. 2014 Jan 17;123:231-5. doi: 10.1016/j.physbeh.2012.06.005. Epub 2012 Jun 15.
Corbalan-Tutau MD, Madrid JA, Garaulet M Timing and duration of sleep and meals in obese and normal weight women. Association with increase blood pressure. Appetite. 2012 Aug;59(1):9-16. doi: 10.1016/j.appet.2012.03.015. Epub 2012 Mar 23.
Garaulet M, Corbalan-Tutau MD, Madrid JA, Baraza JC, Parnell LD, Lee YC, Ordovas JM PERIOD2 variants are associated with abdominal obesity, psycho-behavioral factors, and attrition in the dietary treatment of obesity. J Am Diet Assoc. 2010 Jun;110(6):917-21. doi: 10.1016/j.jada.2010.03.017. Erratum In: J Am Diet Assoc. 2011 Apr;111(4):626.
Garaulet M, Esteban Tardido A, Lee YC, Smith CE, Parnell LD, Ordovas JM SIRT1 and CLOCK 3111T> C combined genotype is associated with evening preference and weight loss resistance in a behavioral therapy treatment for obesity. Int J Obes (Lond). 2012 Nov;36(11):1436-41. doi: 10.1038/ijo.2011.270. Epub 2012 Feb 7.
Garaulet M, Smith CE, Hernandez-Gonzalez T, Lee YC, Ordovas JM PPARgamma Pro12Ala interacts with fat intake for obesity and weight loss in a behavioural treatment based on the Mediterranean diet. Mol Nutr Food Res. 2011 Dec;55(12):1771-9. doi: 10.1002/mnfr.201100437. Epub 2011 Nov 21.
Garaulet M, Vera B, Bonnet-Rubio G, Gomez-Abellan P, Lee YC, Ordovas JM Lunch eating predicts weight-loss effectiveness in carriers of the common allele at PERILIPIN1: the ONTIME (Obesity, Nutrigenetics, Timing, Mediterranean) study. Am J Clin Nutr. 2016 Oct;104(4):1160-1166. doi: 10.3945/ajcn.116.134528. Epub 2016 Sep 14.
Lo MT, Bandin C, Yang HW, Scheer FAJL, Hu K, Garaulet M CLOCK 3111T/C genetic variant influences the daily rhythm of autonomic nervous function: relevance to body weight control. Int J Obes (Lond). 2018 Feb;42(2):190-197. doi: 10.1038/ijo.2017.168. Epub 2017 Jul 24.
Milagro FI, Gomez-Abellan P, Campion J, Martinez JA, Ordovas JM, Garaulet M CLOCK, PER2 and BMAL1 DNA methylation: association with obesity and metabolic syndrome characteristics and monounsaturated fat intake. Chronobiol Int. 2012 Nov;29(9):1180-94. doi: 10.3109/07420528.2012.719967. Epub 2012 Sep 24.
Morales-Falo EM, Sanchez-Moreno C, Esteban A, Alburquerque JJ, Garaulet M [Quality of the diet "before and during" a weight loss treatment based on Mediterranean Diet; behavioural therapy and nutritional education]. Nutr Hosp. 2013 Jul-Aug;28(4):980-7. doi: 10.3305/nh.2013.28.4.6665. Spanish.
Sanchez-Moreno C, Ordovas JM, Smith CE, Baraza JC, Lee YC, Garaulet M APOA5 gene variation interacts with dietary fat intake to modulate obesity and circulating triglycerides in a Mediterranean population. J Nutr. 2011 Mar;141(3):380-5. doi: 10.3945/jn.110.130344. Epub 2011 Jan 5.
Smith CE, Ordovas JM, Sanchez-Moreno C, Lee YC, Garaulet M Apolipoprotein A-II polymorphism: relationships to behavioural and hormonal mediators of obesity. Int J Obes (Lond). 2012 Jan;36(1):130-6. doi: 10.1038/ijo.2011.24. Epub 2011 Mar 8.
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.