NCT05981404 - 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)

Ebbeling CB, Feldman HA, Klein GL, Wong JMW, Bielak L, Steltz SK, Luoto PK, Wolfe RR, Wong WW, Ludwig DS
Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial. BMJ. 2018 Nov 14;363:k4583. doi: 10.1136/b
Fechner E, Smeets ETHC, Schrauwen P, Mensink RP
The Effects of Different Degrees of Carbohydrate Restriction and Carbohydrate Replacement on Cardiometabolic Risk Markers in Humans-A Systematic Review and Meta-Analysis. Nutrients. 2020 Apr 2;12(4):991. doi: 10.3390/nu12040991.
Miyamoto J, Watanabe K, Taira S, Kasubuchi M, Li X, Irie J, Itoh H, Kimura I
Barley beta-glucan improves metabolic condition via short-chain fatty acids produced by gut microbial fermentation in high fat diet fed mice. PLoS One. 2018 Apr 26;13(4):e019657
Thom G, Dombrowski SU, Brosnahan N, Algindan YY, Rosario Lopez-Gonzalez M, Roditi G, Lean MEJ, Malkova D
The role of appetite-related hormones, adaptive thermogenesis, perceived hunger and stress in long-term weight-loss maintenance: a mixed-methods stud
Wang GJ, Tomasi D, Backus W, Wang R, Telang F, Geliebter A, Korner J, Bauman A, Fowler JS, Thanos PK, Volkow ND
Gastric distention activates satiety circuitry in the human brain. Neuroimage. 2008 Feb 15;39(4):1824-31. doi: 10.1016/j.neuroimage.2007.11.00

Impact of ß-glucan Supplementation During Calorie and Carbohydrate Restriction on Subjective Appetite and Gastrointestinal Appetite Hormones in Overweight Adults.

Details for clinical trial NCT05981404

Clinical trial NCT05981404 - References