NCT05558488 - 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)

Balasse EO, Féry F
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Dashti HM, Mathew TC, Hussein T, Asfar SK, Behbahani A, Khoursheed MA, Al-Sayer HM, Bo-Abbas YY, Al-Zaid NS
Long-term effects of a ketogenic diet in obese patients. Exp Clin Cardiol. 2004 Fall;9(3):200-5.
Paoli A, Bosco G, Camporesi EM, Mangar D
Ketosis, ketogenic diet and food intake control: a complex relationship. Front Psychol. 2015 Feb 2;6:27. doi: 10.3389/fpsyg.2015.00027. eCollection 2015. Review.
Paoli A, Grimaldi K, Toniolo L, Canato M, Bianco A, Fratter A
Nutrition and acne: therapeutic potential of ketogenic diets. Skin Pharmacol Physiol. 2012;25(3):111-7. doi: 10.1159/000336404. Epub 2012 Feb 11. Review.
Paoli A, Rubini A, Volek JS, Grimaldi KA
Beyond weight loss: a review of the therapeutic uses of very-low-carbohydrate (ketogenic) diets. Eur J Clin Nutr. 2013 Aug;67(8):789-96. doi: 10.1038/ejcn.2013.116. Epub 2013 Jun 26. Review. Erratum in: Eur J Clin Nutr. 2014 May;68(5):641.
Phinney SD
Ketogenic diets and physical performance. Nutr Metab (Lond). 2004 Aug 17;1(1):2.
Veech RL
The therapeutic implications of ketone bodies: the effects of ketone bodies in pathological conditions: ketosis, ketogenic diet, redox states, insulin resistance, and mitochondrial metabolism. Prostaglandins Leukot Essent Fatty Acids. 2004 Mar;70(3):309-19. Review.

Effect of a Meatless,Ketogenic Restrictive Diet on Body Composition, Concentration of Trimethylamine N-Oxide (TMAO),Ketone Bodies and Glucose in Blood and Urine, Somatic Disorders, Strength Capacity, Oxidative Stress, Immune Response

Details for clinical trial NCT05558488

Clinical trial NCT05558488 - References