|- candidate number||5689|
|- NTR Number||NTR1794|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-mei-2009|
|- Secondary IDs||Sip.2.C/A/2 Danone Research|
|- Public Title||Nonspecific immune function in elderly after 6 weeks intake of the Pentagon module.|
|- Scientific Title||Nonspecific immune function in elderly after 6 weeks intake of the Pentagon module.|
|- hypothesis||Usage of the Pentagon Module will improve nonspecific immune function.|
|- Healt Condition(s) or Problem(s) studied||Elderly patients|
|- 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||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
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);
8. In the last 7 days prior to Visit 1:
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
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;
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).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||27-apr-2009|
|- planned closingdate||1-okt-2009|
|- Target number of participants||64|
|- 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 product which is an isocaloric
Both products are powders that need to be solved prior to intake.
After screening for eligibility weight will be measured 3 times, stool and blood samples will be taken 3 times and tolerance questionnaires will be completed
during 22 days.
(Serious) adverse events will be monitored from start study until 1 week after
completion of the intervention period.
|- Primary outcome||Ex vivo phagocytic capacity of monocytes and granulocytes in whole blood.|
|- Secondary outcome||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.
|- Timepoints||1. Visit 0 = screening (Day -21 max.);|
2. Visit 1 = Day 1 (start of intervention);
3. Visit 2 = Day 21;
4. Visit 3 = Day 42 (end of intervention);
5. Follow Up phone call = Day 49.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Mw. L. Vendrig|
|- CONTACT for SCIENTIFIC QUERIES||PhD MSc S. Hougee|
|- Sponsor/Initiator ||Danone Research B.V.|
(Source(s) of Monetary or Material Support)
|Danone Research B.V. |
|- Brief summary||In this trial the effect of the test product will be compared to the control product on the non-specific immune function in elderly. Subjects will be using the study product twice a day for 6 weeks.|
|- Main changes (audit trail)|
|- RECORD||4-mei-2009 - 26-jan-2010|