Prospective Randomized Controlled Pilot Study of Gut Microbiome Modulation by Nigella Sativa Seed Oil and Thymoquinone Metabolism in Healthy Volunteers

Influence of Thymoquinone on the Human Gut Microbiome

For many patients, the additive use of dietary supplements without side effects is motivating for therapy and enhances quality of life. The oil of the plant Nigella sativa (NS), a dietary supplement containing Thymoquinone (TQ) as its main active compound, exhibits hepatoprotective effects through antioxidative, antifibrotic, and anti-inflammatory properties, and also demonstrates anticancer and antiapoptotic activities. In vitro and in vivo studies have shown that TQ can also influence the gut microbiome. However, no clinical studies are currently available that describe the specific extent of TQ's influence on the human intestinal microbiome and its potential effects on the outcome after gastrointestinal surgery.

The aim of the project is therefore to investigate changes in the human microbiome following the intake of Nigella sativa seed oil capsules containing TQ as the main active ingredient. The study will test the hypothesis that TQ, through its diverse mechanisms of action, modulates the composition of the microbiome and thereby exerts a positive effect on immune response and intestinal healing processes. In parallel, TQ metabolites in urine will be analyzed using Liquid Chromatography-Mass Spectrometry (LC-MS) to gain insights into the pharmacokinetic profile of the compound.

Inclusion Criteria:

• no recent medication use
• no history of gastrointestinal surgery
• no pregnancy
• no allergies to NSSO or its derivatives
• healthy
• 18 years and above

Exclusion Criteria:

• regular medication
• history of gastrointestinal surgery
• pregnancy
• allergies to NSSO or its derivates
• presence of chronic illness
• below the age of 18 years