Agaricus Bisporus and Influenza Vaccination Response

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Influenza vaccine

Agaricus bisporus capsules

Control capsules

About this trial

This is an interventional prevention trial for Immune Response focused on measuring Agaricus bisporus, Immune system, Influenza vaccination, Mushroom

Eligibility Criteria

59 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 60 years or older during influenza season 2023/2024 (in line with RIVM guidelines) BMI between 20 and 35 kg/m2 Willing to abstain from mushrooms other than the capsules containing a mushroom powder as provided by us during the study period. Willing to keep the intake of fish oil, Zinc, Selenium and (vitamin) supplements constant Willing to abstain from products / supplements enriched with Vitamin D Willing to abstain from products / supplements enriched with plant sterols or stanols Willing to abstain from products / supplements enriched with (β)glucans or fungi. Willing to abstain from products / supplements that are mentioned to "boost your immune system" Willing to abstain from (products enriched in) pre/pro-biotics Willing to abstain from products/supplements enriched with ergothioneine Exclusion Criteria: Already received influenza vaccination in 2023 Allergy to mushrooms Known allergic reaction to an active component or other components of the vaccine (e.g. Chicken Eggs) Having donated blood within one month prior to the start of the study, or planning to donate blood during the study Excessive alcohol use (>20 consumptions per week) Regular use of soft and/or hard drugs Using medication for diseases known to affect inflammation/immunity (e.g. inhaled corticosteroids and prednisone)

Sites / Locations

Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Agaricus bisporus group

Placebo group

Arm Description

Dietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each

Dietary supplement: 10 placebo capsules, capsules that do not contain Agaricus bisporus powder

Outcomes

Primary Outcome Measures

Vaccine specific antibody titer

The response to the Influenza vaccine will be measured by quantifying the specific antibody titer

Secondary Outcome Measures

Immune parameters (1)

Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system

Immune parameters (2)

hsCRP

Leukocyte count

Number of leukocytes measured in EDTA plasma

Leukocyte differential count

Number of subgroups of leukocytes measured in EDTA plasma

Fasted metabolism (1)

Serum non-cholesterol sterols and stanols

Fasted metabolism (2)

Serum lipid and lipoprotein profile

Fasted metabolism (3)

Plasma glucose

Fasted metabolism (4)

Ergothioneine

Fasted metabolism (5)

Glutathione

Fasted metabolism (6)

Malondialdehyde

Anthropometry (1)

Body weight

Anthropometry (2)

Height

Anthropometry (3)

Waist circumference

Anthropometry (4)

Hip circumference

Anthropometry (5)

Waist-to-hip ratio

Diet

Food frequency questionnaire is used to determine if the participants maintain their habitual diet and to determine if the participants do not consume mushrooms outside the intervention

Quality of life questionnaire

Quality of life questionnaire is used to determine the participants overall wellbeing and quality of life

Diary outcomes (1)

Adverse events as assessed by the diary

Diary outcomes (2)

Medication intake as assessed by the diary

Full Information

NCT ID

NCT06041867

First Posted

September 11, 2023

Last Updated

September 11, 2023

Sponsor

Maastricht University Medical Center

Collaborators

Scelta Mycofriends B.V., CNC Grondstoffen B.V.

1. Study Identification

Unique Protocol Identification Number

NCT06041867

Brief Title

Agaricus Bisporus and Influenza Vaccination Response

Official Title

Mushboost: Evaluating the Effect of Agaricus Bisporus Powder Intake on the Vaccination Response to an Influenza Vaccine

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 14, 2023 (Anticipated)

Primary Completion Date

December 22, 2023 (Anticipated)

Study Completion Date

May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

Collaborators

Scelta Mycofriends B.V., CNC Grondstoffen B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

There are numerous in vitro and animal studies that suggested that mushrooms beneficially influence the immune system. We have recently shown that a wild isolate of the edible Agaricus bisporus mushroom had a clear effect on parameters reflecting a better function of the immune system, both in vitro and in vivo in animals. The question now is whether this efficacy can also be translated to humans. In humans, measuring the antibody response is the golden standard to evaluate immune function. If Agaricus bisporus powder indeed has beneficial effects on the immune system, people with overweight or obesity and higher age might benefit from consuming Agaricus bisporus powder prior to receiving the influenza vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune Response

Keywords

Agaricus bisporus, Immune system, Influenza vaccination, Mushroom

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Agaricus bisporus group

Arm Type

Experimental

Arm Description

Dietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Dietary supplement: 10 placebo capsules, capsules that do not contain Agaricus bisporus powder

Intervention Type

Biological

Intervention Name(s)

Influenza vaccine

Intervention Description

Single dose of the Influenza vaccine Participants have to wait until they are invited to receive the vaccine by the general practitioner; this study does not interfere with national planning of the vaccine

Intervention Type

Dietary Supplement

Intervention Name(s)

Agaricus bisporus capsules

Intervention Description

Participants have to consume 10 capsules per day containing 500 mg Agaricus bisporus powder each, corresponding to a total Agariicus bisporus powder intake of 5 g daily

Intervention Type

Dietary Supplement

Intervention Name(s)

Control capsules

Intervention Description

Participants have to consume 10 capsules per day containing 500 mg maltodextrin each, corresponding to a total maltodextrin intake of 5 g daily

Primary Outcome Measure Information:

Title

Vaccine specific antibody titer

Description

The response to the Influenza vaccine will be measured by quantifying the specific antibody titer

Time Frame

Maximal change form T=0 (change T=0 to T=3 weeks or T=4 weeks)

Secondary Outcome Measure Information:

Title

Immune parameters (1)

Description

Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system

Time Frame