NCT03628365 - 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)

Deutz NE, Matheson EM, Matarese LE, Luo M, Baggs GE, Nelson JL, Hegazi RA, Tappenden KA, Ziegler TR; NOURISH Study Group
Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: A rando
Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR
Effect of ß-hydroxy-ß-methylbutyrate (HMB) on lean body mass during 10 days of bed rest in older adults. Clin Nutr. 2013 Oct;32(5):704-12. doi: 10.1016/j.clnu.2013.02.011. Epub 2013 M
Engelen MPKJ, Deutz NEP
Is ß-hydroxy ß-methylbutyrate an effective anabolic agent to improve outcome in older diseased populations? Curr Opin Clin Nutr Metab Care. 2018 May;21(3):207-213. doi: 10.1097/MCO.0000000000000459. Review.

Can Beta-Hydroxy-beta-Methylbutyrate (HMB) Supplementation Counteract Muscle Catabolism in Critically Ill Patients? A Randomized Controlled Trial

Clinical trial NCT03628365 - References