A proof of concept study to evaluate the impact of a food supplement on production of short chain fatty acids and microbiome in healthy subjects

A proof of concept study to evaluate the impact of a food supplement on production of short chain fatty acids and microbiome in healthy subjects - BTS1426/19

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023166

Enrollment

Registered

2020-09-25

Start date

2020-10-05

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 volunteers

Interventions

Group 1: Food supplements with probiotic, dipeptide, plant extracts as well as vitamins and minerals. Intake: 1 capsule in the morning - and 1 capsule in the evening - with sufficient liquid for 4 wee

Eligibility

Sex/Gender

Male

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Subject is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry, haematology, Busy men with health unconscious eating patterns, BMI: 19-30 kg/m², Non-smoker

Exclusion criteria

Exclusion criteria: • Relevant history or presence of any severe medical disorder, potentially interfering with this study • Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries, use of PPIs, bismuth salts and/or H2-antagonists • Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery • Vegetarians, vegans • Subjects consuming food or drinks claimed as ‘probiotic’, or ‘prebiotic more than once weekly or food or drinks claimed as ‘rich in fiber’ (including specific milk products) more than 3 times per week ormore than 3 portions of fruits and vegetables (sum) per day • Subjects with stool frequency of = 2 stools per week • Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study. • Relevant allergy or known hypersensitivity against compounds of the study preparations • Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study • Anticipating any planned changes in lifestyle or physical activity levels for the duration of the study

Design outcomes

Primary

Measure	Time frame
Production of short chain fatty acids (SCFA) after 4 weeks	—

Secondary

Measure	Time frame
Changes in microbiome after 4 week, Impact on stool consistency an frequency	—

Countries

Germany

Contacts

Public ContactTanita Dharsono

BioTeSys GmbH

a.studie@biotesys.de0711 310 57 141

Outcome results

None listed

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