Quality control bioassays for nutriceutical and medicinal products

摘要

Bioassays for detecting the ability of one sample of a food substance, nutritional supplement, therapeutic agent and/or disease preventive agent relative to that of a second sample of such a substance, supplement and/or agent to inhibit, upregulate or otherwise modulate translation initiation, and thereby demonstrate a disease curative and/or preventive effect in a human and/or animal that consumes a such substance, supplement and/or agent or to whom a such substance, supplement and/or agent is administered are provided.

主权项

1. An in vitro method for identifying whether a sample contains n-3 polyunsaturated fatty acid (PUFA) activity comprising the steps of:
providing a first test system including a first mRNA sequence encoded by a first biomarker gene having a coding region for a first reporter protein operably linked to a first biomarker promoter; providing a second test system including a second mRNA sequence encoded by a second biomarker gene having a coding region for a second reporter protein operably linked to a second biomarker promoter; contacting said second test system with the sample; and detecting transcription levels of said first and said second mRNA sequences, and identifying the sample as containing PUFA activity if the sample mediates transcriptional upregulation of the second biomarker gene or (b) wherein the transcription level of said second mRNA sequence is greater than the transcription level of said first mRNA sequence, and wherein said first and said second biomarker genes are members selected from the group consisting of nucleic acid sequences that encode pro-apoptotic C/EBP homologous protein (CHOP), ER chaperone binding protein (BiP), Activating Transcription Factor 4 (ATF-4), and X-box binding protein 1 (Xbp-1).