Elderly subjects (male and female)
Conditions
Interventions
Duration of intervention: 6 weeks (total duration study maximal 10 weeks).
Test group: Twice daily intake of the test product named Pentagon module.
Control group: Twice daily intake of the control
Sponsors
Danone Research - Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Elderly subject (male/female) = or > 65 years of age; 2. 19.0 kg/m2 < BMI < 32.0 kg/m2; 3. Subject is willing and able to comply with the protocol, including: A. Refrain 3 weeks prior to start study (Visit 1) and for the duration of the study from: a. The use of probiotic supplements and food containing probiotics; b. The use of prebiotic or fibre containing supplements; c. The use of the n-3 fatty acids EPA and/or DHA containing supplements (e.g. fish oil); d. The use of non-steroidal anti-inflammatory drugs (NSAIDs). B. Maintaining dietary habits for the duration of the study; C. Filling in a tolerance questionnaire (Day -4-14, Day 38 - 41). 4. Non-smoking since 6 months prior to start study (Visit 1); 5. Regular bowel movement (at least 1 bowel movement in 3 days); 6. Subject has given written informed consent.
Exclusion criteria
Exclusion criteria: 1. Any (history of) gastrointestinal disease or surgery that interferes with current gastrointestinal function (e.g. inflammatory bowel disease, gastroparesis, gastrectomy); 2. Known allergy to milk, milk products; 3. Diabetes mellitus; 4. Any form of cancer in the last 5 years prior to Visit 1, except basal cell carcinomas; 5. Lactose intolerance (that cannot be managed with lactase tablets /capsules /drops); 6. Strong dislike of the flavour orange; 7. Any altered immune function, such as: A. Any allergy (e.g. hay fever, dust mite allergy); B. Any auto-immune disease (e.g. rheumatoid arthritis); C. Psoriasis. 8. In the last 7 days prior to Visit 1: A. Fever; B. Gastrointestinal symptoms such as nausea, vomiting, diarrhea; C. Respiratory symptoms such as cough, runny or congested nose, sore throat; 9. Medication within 3 weeks prior to start study (Visit 1) or planned during study period: A. That interferes with current gastrointestinal function (e.g. opiates. laxatives, H2 receptor antagonists, proton pump-inhibitors); B. Anti-asthma medication; C. Anti-allergy medication; D. Antibiotics; E. (Any kind of) immunosuppressive drugs including corticosteroids (oral, inhaled or topical); F. Non-steroidal anti-inflammatory drugs, including low dose aspirin. 10. Planned hospitalization during the study period; 11. Recent (unintended) weight loss of more than 5% in the 4 weeks prior to start of study (Visit 1); 12. Requirement for any nutritional support; 13. Requirement for a fibre-free diet; 14. On a weight loss or vegetarian diet; 15. Current alcohol use of more than 21 glasses per week for males or 14 glasses per week for females or drug abuse; 16. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements; 17. Participation in any other intervention study concomitantly or within 12 weeks of study entry (Visit 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ex vivo phagocytic capacity of monocytes and granulocytes in whole blood. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ex vivo oxidative burst capacity of monocytes and granulocytes in whole blood; 2. NK cell activity in PBMC; 3. NK cell number in PBMC; 4. Gut microbiota composition (e.g. % of bifidobacteria, lactobacilli); 5. Faecal parameters: pH, short-chain fatty acids, lactic acid; 6. Tolerance and safety parameters: tolerance by questionnaires, adverse events, laboratory safety parameters. | — |
Contacts
Public ContactL. Vendrig
Julius Centrum voor Gezondheidswetenschappen en Eerstelijns Geneeskunde
Outcome results
None listed