Relatively healthy elderly persons (over 64 years) Digestive System Relatively healthy elderly persons (over 64 years)
Conditions
Interventions
Participants are randomly allocated to one of two groups. Randomisation is prepared by study statistician using statistical analysis software SAS 9.2 and participants are randomly allocated to one of
Sponsors
BioCC OÜ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Aged over 64 years 3. Willingness to maintain a stable diet and physical activity level 4. Normal laboratory values with exception detailed in protocol 5. Normal, high normal and grade 1 systolic / diastolic blood pressure (=159/99 mm Hg) 6. Normal, high normal and mild hypercholesterolemia
Exclusion criteria
Exclusion criteria: 1. Pregnancy and breastfeeding 2. (Food) allergy 3. Intolerance to the investigational product / its ingredients 4. Diabetes 5. Eating disorder 6. Active weight loss > 5 kg in prior 3 months 7. Extensive exercise (daily trainings of professional athletes) 8. Drug or alcohol abuse 9. Participation in other studies within the last 30 days / during the study 10. Any history of gastrointestinal diseases 11. Acute infection within the last 2 weeks prior to baseline 12. Use of any antimicrobial agents within the preceding 1 month 13. Donor within the last 1,5 months prior to start of the study (i.e. baseline visit) 14. Use of any pre-, probiotic or food supplement within the last 2 weeks prior to start of the study 15. Chronic inflammatory diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events are measured using the patient diary (follow chart), self administered follow-up questionnaire filled once per week, patient interviews at baseline, day three and day 21. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Presence of L. plantarum INDUCIA is measured by molecular methods from stool samples collected at baseline, between day 8 to 14, day 21, and between day 28-30 2. Occurrence of Clostridium difficile is measured by RIDA®QUICK Clostridium difficile GDH test and molecular methods from stool samples collected at baseline and day 21 3. Lipidogram is measured using blood tests at baseline and day 21 4. Level of ox-LDL values are measured using blood tests (using ELISA) at baseline and day 21 5. Primary and secondary bile acids are measured from stool samples using High Pressure Liquid Chromatograph (HPLC) at baseline and day 21 6. Short chain fatty acids are measured from stool samples using High Pressure Liquid Chromatograph (HPLC) at baseline and day 21 7. Evidence METS I (ferritin, interleukin-6 (IL-6), insulin, leptin, Plasminogen Activator Inhibitor-1 (PAI-1), resistin, Tumour Necrosis Factor a (TNFa)) are measured from fasting blood plasma using Randox Evidence Investigator at baseline and day 21 | — |
Countries
Estonia
Outcome results
None listed