NCT06321211 - 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)

Abenavoli L, Greco M, Milic N, Accattato F, Foti D, Gulletta E, Luzza F
Effect of Mediterranean Diet and Antioxidant Formulation in Non-Alcoholic Fatty Liver Disease: A Randomized Study. Nutrients. 2017 Aug 12;9(8):870. doi: 10.3390/nu9080870.
Anania C, Perla FM, Olivero F, Pacifico L, Chiesa C
Mediterranean diet and nonalcoholic fatty liver disease. World J Gastroenterol. 2018 May 21;24(19):2083-2094. doi: 10.3748/wjg.v24.i19.2083.
Romero-Gomez M, Zelber-Sagi S, Trenell M
Treatment of NAFLD with diet, physical activity and exercise. J Hepatol. 2017 Oct;67(4):829-846. doi: 10.1016/j.jhep.2017.05.016. Epub 2017 May 23.

Development of a Novel Asian Mediterranean Diet and Its Acceptability in Non- Alcoholic Fatty Liver Disease (NAFLD)- a Pre-intervention Study

Clinical trial NCT06321211 - References