GMA
Overall microbial diversity remained stable while selected taxa changed; thymoquinone and metabolites were detected qualitatively in urine.
The prospective pilot randomised eight healthy adults: four received thymoquinone-containing Nigella sativa seed-oil capsules for twenty days and four formed an untreated control group. The study was open-label and used no placebo.
16S analyses found no significant differences in alpha or beta diversity but identified exploratory changes in selected taxa. Thymoquinone and/or dihydrothymoquinone were detected qualitatively in urine after repeated intake.
The work demonstrates sampling feasibility and provides an initial human signal, not evidence of benefit. The very small sample, uncontrolled diet and absence of blinding require confirmation in larger placebo-controlled trials with quantitative pharmacokinetic analysis.
The design connects active standardisation, human exposure and microbiome response — three useful stages in branded-botanical development.
Only eight participants, open-label design, no placebo and retrospective registration. The study cannot establish efficacy or pharmacokinetics.
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