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A Nutritional intervention study to evaluate the effect Of Bovine Lactoferrin on innate immunity in Elderly people

A Nutritional intervention study to evaluate the effect Of Bovine Lactoferrin on innate immunity in Elderly people - NOBLE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43339
Enrollment
30
Registered
2016-08-15
Start date
2017-01-12
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ontsteking Immunosenescence weakening of the immune system

Interventions

The intervention group will receive 3 weeks supplementation with LF only, followed by 3 weeks LF + GOS, followed by 3 weeks LF + GOS + vitamin D. The placebogroup will receive maltodextrin.

Sponsors

FrieslandCampina Nederland BV
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Female * Age 65-85 years (if sufficient candidate participants are available, subjects with a higher age (preferentially >

Exclusion criteria

Exclusion criteria: * Having chronic inflammatory or autoimmune diseases such as rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease * Disease of GI tract (including major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, known or suspected gastrointestinal disorders, colon or GI tract cancer), liver, gall bladder, kidneys, thyroid gland * Immune-compromised * Use of vitamin supplements containing vitamin D and not willing to discontinue this during the study * Use of anti-inflammatory drugs (for corticosteroids and NSAIDs : frequency >1 per week) * Use of immunosuppressive drugs * Excessive alcohol usage (>3 consumptions/day or >15 consumptions/week) * Participation in any clinical trial including blood sampling and/or administration of substances within 60 days before inclusion in this study * Use of hormonal replacement therapy * Mental status that is incompatible with the proper conduct of the study * A self-reported milk allergy or sensitivity to dairy ingredients * Unexplained weight loss or weight gain of > 3 kg in the 3 months prior to pre-study screening * First and second degree relatives of personnel of NIZO food research or Wageningen University, department of Cell Biology and Immunology or Human Nutrition * Not having a general practitioner * Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results and eventual adverse events to and from his general practitioner * Holiday to a sunny country during the study, starting from inclusion * Light therapy during the study, starting from inclusion * Use of prebiotic supplements during 2 months before study start, and during the study

Design outcomes

Primary

MeasureTime frame
IFN-a and IL-6 production by PBMCs upon ex vivo TLR7 stimulation.

Secondary

MeasureTime frame
- TNF-a production by PBMCs upon ex vivo TLR7 stimulation - the percentage IFN-a-, IL-6- or TNF-a-producing pDCs in PBMCs upon ex vivo TLR7 stimulation The study will have an additional exploratory character, by analyzing the ex vivo PBMC response to various TLR-stimuli. Also other inflammatory markers and markers of osteoarthritis will be measured in serum/plasma. In case of positive outcomes for any of the 3 dietary subsequent intervention periods, fecal samples will be used for analysis of microbiota, SCFAs, and markers of inflammation and gut barrier function (e.g. calprotectin).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)