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

Evonik Operations GmbH0 sites18 target enrollmentSeptember 25, 2020

Overview

No summary available.

Registry

who.int

Start Date

September 25, 2020

End Date

December 21, 2020

Last Updated

last year

Study Type

Interventional

Sex

Male

Sponsor

•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

•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