NCT04078971 - 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)

Paoli A, Bianco A, Grimaldi KA
The Ketogenic Diet and Sport: A Possible Marriage? Exerc Sport Sci Rev. 2015 Jul;43(3):153-62. doi: 10.1249/JES.0000000000000050. Review.
Paoli A, Grimaldi K, D'Agostino D, Cenci L, Moro T, Bianco A, Palma A
Ketogenic diet does not affect strength performance in elite artistic gymnasts. J Int Soc Sports Nutr. 2012 Jul 26;9(1):34. doi: 10.1186/1550-2783-9-34.
Rubini A, Bosco G, Lodi A, Cenci L, Parmagnani A, Grimaldi K, Zhongjin Y, Paoli A
Erratum to: Effects of Twenty Days of the Ketogenic Diet on Metabolic and Respiratory Parameters in Healthy Subjects. Lung. 2017 Feb;195(1):155. doi: 10.1007/s00408-016-9958-0.

Effects of a Very Low Carbohydrate Ketogenic Diet on Body Composition, Muscle Strength, Muscle Area, Metabolism and Performance in Semi-professional Soccer Players

Details for clinical trial NCT04078971

Clinical trial NCT04078971 - References