Effect of a food supplement with a T. serpylli extract to evaluate the impact on gut health, microbiome and metabolic properties: a randomized double blind placebo-controlled study with two dosages

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00026074

Enrollment

Registered

2021-08-11

Start date

2021-08-30

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy participants

Interventions

Group 1: Intervention phase I: 600 mg T. serpylli extract, orally 1x daily

(Supplementation 4 weeks)

Intervention phase II: 900 mg T. serpylli extract, orally 1x daily, (supplementation 4 weeks) Group 2: Placebo: maltodextrin

Intervention phase I: 600 mg, orally 1x daily (supplementation 4 weeks)

Intervention phase II: 900 mg, orally 1x daily (supplementation 4 weeks)

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Inclusion criteria

Inclusion criteria: - Healthy individuals with no clinically diagnosed gastrointestinal disorders - Women and men with mild to moderate gastrointestinal complaints - BMI: 25.0 - 35.0 kg / m2 - Frequency of stool: 2 - 5 stools per week - non-smokers

Exclusion criteria

Exclusion criteria: - Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.) - Subject under prescription for medication or taking dietary supplements possibly interfering with this study (such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries, use of PPIs, bismuth salts and/or H2-antagonists, fibers etc.) within 2 weeks prior to study start or during the study o Intake of antibiotics in the last month and laxatives in the last 2 weeks prior to study start o Vegetarians, vegans o Subjects consuming-food or drinks claimed as ‘probiotic’, or ‘prebiotic’ more than once weekly -food or drinks claimed as ‘rich in fiber’ (including specific milk products) more than 3 times per week -more than 3 portions of fruits and vegetables (sum) per day o Subjects with diarrhoeal stool type (Bristol scale type 7) = 1 per week

Design outcomes

Primary

Measure	Time frame
Change in the following parameters in blood and faces between baseline and after 4-week intervention with the two doses compared with placebo: o Gastrointestinal symptoms GSRS (Gastrointestinal Symptom Rating Scale) Questionnaire o Gut microbiota: 16S-rRNA analysis o Stool frequency o Stool consistency with Bristol stool form scale o Short chain fatty acids (SCFA) o Alpha-1-antitrypsin o Secretory IgA o Inflammatory biomarkers: (e.g., hsCRP, cytokine panel) o Lipid status, Fasting glucose, Insulin and HOMA Index o I-FABP o ox-LDL	—

Measure

Time frame

Change in the following parameters in blood and faces between baseline and after 4-week intervention with the two doses compared with placebo: o Gastrointestinal symptoms GSRS (Gastrointestinal Symptom Rating Scale) Questionnaire o Gut microbiota: 16S-rRNA analysis o Stool frequency o Stool consistency with Bristol stool form scale o Short chain fatty acids (SCFA) o Alpha-1-antitrypsin o Secretory IgA o Inflammatory biomarkers: (e.g., hsCRP, cytokine panel) o Lipid status, Fasting glucose, Insulin and HOMA Index o I-FABP o ox-LDL

—

Secondary

Measure	Time frame
Additional parameters: o Quality of life (SF-12) o BMIS (Brief Mood Introspection Scale) o PSQ20 (Perceived Stress Questionnaire) o Global assessment	—

Countries

Germany

Contacts

Public ContactKatharina Knaub

Biotesys GmbH

k.knaub@biotesys.de+49 (0) 711/3513835

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026