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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

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The optimal consumption is at least 30 minutes before or 90 minutes after a meal with 250 ml of still, lukewarm water or optionally with a teaspoon of omega-3 oil to increase bioavailability

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