Childhood Obesity — Effects of COcoa Supplement in OBese Adolescent Subjects
Citation(s)
Aceves-Martins M, Llauradó E, Tarro L, Solà R, Giralt M Obesity-promoting factors in Mexican children and adolescents: challenges and opportunities. Glob Health Action. 2016 Jan 18;9:29625. doi: 10.3402/gha.v9.29625. eCollection 2016. Review.
Almoosawi S, Tsang C, Ostertag LM, Fyfe L, Al-Dujaili EA Differential effect of polyphenol-rich dark chocolate on biomarkers of glucose metabolism and cardiovascular risk factors in healthy, overweight and obese subjects: a randomized clinical trial. Foo
Becker K, Geisler S, Ueberall F, Fuchs D, Gostner JM Immunomodulatory properties of cacao extracts - potential consequences for medical applications. Front Pharmacol. 2013 Dec 12;4:154. doi: 10.3389/fphar.2013.00154. Review.
Gupta N, Goel K, Shah P, Misra A Childhood obesity in developing countries: epidemiology, determinants, and prevention. Endocr Rev. 2012 Feb;33(1):48-70. doi: 10.1210/er.2010-0028. Epub 2012 Jan 12. Review.
Kim J, Lee I, Lim S Overweight or obesity in children aged 0 to 6 and the risk of adult metabolic syndrome: A systematic review and meta-analysis. J Clin Nurs. 2017 Dec;26(23-24):3869-3880. doi: 10.1111/jocn.13802. Epub 2017 May 23. Review.
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.
