Healthy subjects
Conditions
Interventions
Group 1: Food supplement with >1 billion colony forming units of Bacillus megaterium DSM 32963, 596 mg Omega-3 lysin complex, 55 µg Selenium, oral, 2x 1 capsule/day
Intervention: 28 days
Group 3: Reference product (secondary): Fish oil, 1000 mg, oral, 2x 1 capsule/day
Intervention 28 days
Sponsors
Evonik Operations GmbH
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Women and men with low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less (minimum 25% of each gender) (2) BMI: 19-35 kg/m² (3) Omega-3 index in erythrocytes: = 6.0 % at screening (4) Classification as “at-risk individual” according to AGE (advanced glycation end products) reader (5) hsCRP level = 1 mg/L at screening visit (6) Non-smoker (7) Subject is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry, haematology (8) Written consent to participate in the study (9) Able and willing to follow the study procedures
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, chronic intake of NSAR or acetylsalicylic acid, glucocorticoids 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) Vegans (6) Subjects consuming • food or drinks claimed as ‘probiotic’ more than once weekly (7) Subjects with stool frequency of = 2 stools per week (8) Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study (9) Relevant allergy or known hypersensitivity against compounds of the study preparations (e.g. fish) (10) Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study (11) Anticipating any planned changes in lifestyle or physical activity levels for the duration of the study (12) Not willing to abstain on fish consumption or foods / oils high in omega-3 fatty acids, e.g. linseed oil etc. (13) If female: currently pregnant, planning to become pregnant during the study period, breastfeeding (a pregnancy test will be conducted during screening and visits 1 and 3) (14) Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - Single SPMs: resolvins from EPA and DHA, protectins and maresins (Day 1, 3 and 28) - EPA and DHA in plasma (Day 1, 3 and 28) - Omega-3-Index (Day 1 and 28) - Impact on antiinflammatory biomarker (Day 1 and 28) (optionally) - Leaky gut marker in blood (Day 1 and 28) (optionally) - Stool biomarker and microbiota (Day 1 and 28) (optionally) - Metabolic biomarker (e.g. Lipid status, HOMA-index) (Day 1 and 28) | — |
Primary
| Measure | Time frame |
|---|---|
| SPM (specialized pro-resolving mediator) formation: sum of 18-HEPE and 5-HEPE over a period of 28 days and comparison to placebo | — |
Countries
Germany
Contacts
Public ContactChristiane Schön
BioTeSys GmbH
Outcome results
None listed