Healthy volunteers
Conditions
Interventions
Group 1: Dietary supplement in capsule format with microorganisms
omega-3-Lysin-complex, hyaluronic acid, coenzyme Q10, biotin, lecithin (from sunflower), vitamins C, D and B12, zink, selenium.
Two c
Sponsors
Evonik Operations GmbH
Eligibility
Sex/Gender
Female
Age
35 Years to 60 Years
Inclusion criteria
Inclusion criteria: BMI 25-35, Omega-3 Index < 6%, Non-smoker
Exclusion criteria
Exclusion criteria: (1) 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.) (2) Subject under prescription for medication or taking dietary supplements possibly interfering with this study (such as omega-3 fatty acids, probiotics, 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 (3) Intake of antibiotics in the last 2 months and laxatives in the last 2 weeks (4) Significant changes in lifestyle or medication (within last 2 months) or surgical intervention or surgical procedure such as bariatric surgery (5) Subjects consuming • food or drinks claimed as ‘probiotic’ more than once weekly • more than 3 portions of fruits and vegetables (sum) per day (6) Subjects with stool frequency of = 2 stools per week (7) Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study. (8) Relevant allergy or known hypersensitivity against compounds of the study preparations (9) Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study (10) Anticipating any planned changes in lifestyle or physical activity levels for the duration of the study (11) Not willing to abstain on fish consumption or foods / oils high in omga-3 fatty acids, e.g. linseed oil etc. (12) Known pregnancy, breastfeeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and visits 1 and 5. (13) Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increased levels of omega-3 fatty acids and -metabolites in blood on days 1 and 29 after first intake of the study product, measured per UPLC-MS/MS and GC. | — |
Secondary
| Measure | Time frame |
|---|---|
| Increase of omega-3 index (day 1 and day 29 after first ingestion of the study product), Modulation of immune cell differentiation (day 1 and 29), Modulation of inflammatory parameters (day 1, 15, 29), Modulation of the epigenome and the stool microbiota (day 1 and 29). | — |
Countries
Germany
Contacts
Public ContactChristiane Schön
BioTeSys GmbH
Outcome results
None listed