NCT04851041 - 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)

Camire ME, Kubow S, Donnelly DJ
Potatoes and human health. Crit Rev Food Sci Nutr. 2009 Nov;49(10):823-40. doi: 10.1080/10408390903041996. Review.
Jacome-Sosa M, Parks EJ, Bruno RS, Tasali E, Lewis GF, Schneeman BO, Rains TM
Postprandial Metabolism of Macronutrients and Cardiometabolic Risk: Recent Developments, Emerging Concepts, and Future Directions. Adv Nutr. 2016 Mar 15;7(2):364-74. doi: 10.3945/an.115.010397. Print 2016 Mar. Review.
King JC, Slavin JL
White potatoes, human health, and dietary guidance. Adv Nutr. 2013 May 1;4(3):393S-401S. doi: 10.3945/an.112.003525. Review.
Robertson TM, Alzaabi AZ, Robertson MD, Fielding BA
Starchy Carbohydrates in a Healthy Diet: The Role of the Humble Potato. Nutrients. 2018 Nov 14;10(11). pii: E1764. doi: 10.3390/nu10111764. Review.
Seidelmann SB, Claggett B, Cheng S, Henglin M, Shah A, Steffen LM, Folsom AR, Rimm EB, Willett WC, Solomon SD
Dietary carbohydrate intake and mortality: a prospective cohort study and meta-analysis. Lancet Public Health. 2018 Sep;3(9):e419-e428. doi: 10.1016/S2468-2667(18)30135-X. Epub 2018 Aug 17.
Shan Z, Rehm CD, Rogers G, Ruan M, Wang DD, Hu FB, Mozaffarian D, Zhang FF, Bhupathiraju SN
Trends in Dietary Carbohydrate, Protein, and Fat Intake and Diet Quality Among US Adults, 1999-2016. JAMA. 2019 Sep 24;322(12):1178-1187. doi: 10.1001/jama.2019.13771.
Simpson SJ, Le Couteur DG, James DE, George J, Gunton JE, Solon-Biet SM, Raubenheimer D
The Geometric Framework for Nutrition as a tool in precision medicine. Nutr Healthy Aging. 2017 Dec 7;4(3):217-226. doi: 10.3233/NHA-170027. Review.

Long-term Effects of a Potato-based Food Pattern vs a Rice / Pasta-based Food Pattern on Fasting & Postprandial Cardiometabolic Health; The LoPoCardio - Trial

Details for clinical trial NCT04851041

Clinical trial NCT04851041 - References