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

NCT07450807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-03-05

No results posted yet for this study

Summary

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.

Conditions

  • Changes in Human Gut Microbiome in Healthy Adults

Interventions

DIETARY_SUPPLEMENT

Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsules

Intake of two Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsules three times daily for 20 days and provision of fecal samples at five time points.

Sponsors & Collaborators

  • Interdisciplinary Center of Clinical Research of the Medical Faculty Jena

    collaborator UNKNOWN

  • Aysun Tekbaş

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2025-03-01
Completion
2025-03-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07450807 on ClinicalTrials.gov