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Key gaps include: No large-scale randomised controlled trials in humans the evidence basis for clinical use is extrapolated from animal data and small pilot studies No long-term safety data effects beyond 1216 weeks are not well characterised Variable results in human sleep trials some early human studies showed modest or inconsistent effects on sleep architecture compared to animal data, suggesting the translation may not be linear No FDA approval DSIP is not approved for any therapeutic use in the United States Stability concerns DSIP degrades relatively quickly in circulation

Dietary intake and body mass index influence the risk of islet autoimmunity in genetically at-risk children: a mediation analysis using the TEDDY cohort

Furthermore, some animal studies also did not report any change in glutathione content in different tissues (such as the liver, lens and erythrocytes) in riboflavin-deficient animals ( Reference Bates 27 Reference Rao and Bhat 29 )