Healthy elderly subjects, immunosenescence Haematological Disorders Healthy elderly subjects
Conditions
Interventions
75 elderly subjects were enrolled and randomly allocated evenly in three groups using a computer-generated restricted randomization list. At enrolment, they received 28 days of the supplement and comp
Sponsors
Complife Italia Srl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged from 60 to 80 years on the day of inclusion 2. Ability to comply with all the trial procedures 3. Received an influenza vaccine more than 12 months prior to enrolment 4. Body Mass Index (BMI) between 18.5 and 24.99 5. Willingness to not vary the daily diet, fluid intake, and exercise routine during the trial period 6. Willingness to follow the proposed alimentary supplement for the trial period 7. Willingness to use only the supplement being tested during the trial period 8. Willingness to not use products likely to interfere with the product to be tested 9. Informed consent is given
Exclusion criteria
Exclusion criteria: 1. Contraindications to the influenza vaccine 2. Immune system modulation treatment received within 4 weeks of the trial period 3. Immunosuppressant therapy lasting more than 2 weeks or stopped less than 3 months prior to the trial period 4. Influenza vaccination within one year of the trial period 5. Current antibiotic treatment 6. Known history of a chronic medical condition such as congenital heart disease, liver or kidney disease, or immune deficiency 7. Treatment with probiotics within 6 months of the trial period 8. Severe concurrent disease 9. Drug abuse 10. Alcohol abuse 11. Use of fiber products within 6 weeks of the trial period 12. Normal dietary intake exceptionally high in plant-based, high-fiber foods (fruits, vegetables, beans, whole grains, fortified foods), including those following a strict vegetarian diet 13. Dietary intake of probiotics 14. Pre-existing hypersensitivity to components contained in the probiotic 15. Any condition that the principal investigator deems inappropriate for participation 16. Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated). 17. Subjects who have been recently involved in any other similar study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Combined immunodeficiency symptoms, measured using a questionnaire of related symptoms, on a 4 points score at baseline and 28 days 2. Fecal calprotectin levels, determined by ELISA assays on stool samples collected at baseline and 28 days 3. Fecal beta-defensin 2 levels, determined by ELISA assays on stool samples collected at baseline and 28 days 4. Salivary IgA levels, determined by ELISA assays on salivary samples collected at baseline and 28 days. 5. Total Antioxidant Capacity, determined by FRAP assays on salivary samples collected at baseline and 28 days 6. Gut microbiota composition, determined through fecal microbiological analyses using V3-V4 16S NGS sequencing on DNA from stool samples collected at baseline and 28 days 7. Gut colonization, determined through fecal microbiological analysis using species-specific qPCR on DNA from stool samples collected at baseline and 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maintenance of combined immunodeficiency symptoms one month after treatment, determined using the questionnaire of related symptoms, based on a 4 points score at baseline, 28 and 56 days 2. Maintenance of fecal calprotectin levels one month after treatment, determined by ELISA assays on stool samples collected at baseline, 28 and 56 days 3. Maintenance of fecal beta-defensin 2 levels one month after treatment, determined by ELISA assays on stool samples collected at baseline, 28 and 56 days 4. Maintenance of salivary IgA levels one month after treatment, determined by ELISA assays on salivary samples collected at baseline, 28 and 56 days 5. Maintenance of total antioxidant capacity one month after treatment, determined by FRAP assays on salivary samples collected at baseline, 28 and 56 days 6. Maintenance of gut microbiota composition one month after treatment, determined through fecal microbiological analyses using V3-V4 16S NGS sequencing on DNA from stool samples collected at baseline, 28 and 56 days | — |
Countries
Italy
Outcome results
None listed