Plain English Summary
Background and study aims
The immune system is a system of biological structures and processes that are in charge of protecting the human body from various harmful agents that can damage it. It protects the body from things that could make us ill or cause death, such as bacteria and viruses. The immune system takes time to mature, which means that children under five years of age are more susceptible to infections such as diarrhea and the common cold. One way to help children’s immune systems fight off common infections is to give them food supplements that have extra ingredients designed to strengthen the immune system. A common ingredient used to boost food supplements is called beta-glucan. Beta-glucans come from plants and fungi (mushrooms), and they are well known to help support the immune system. The aim of this study is to see whether a food supplement containing beta-glucans derived from the mushroom Ganoderma lucidum can help boost the immune system of children aged 3 to 5 years old.
Who can participate?
Children attached to the Childcare Foundation - Medellin (Fundación de Atención a la Niñez (FAN) – Medellin)
What does the study involve?
Participants are given a nutritional supplement with added beta-glucan to take 5 days a week for 6 weeks. Blood tests are carried out at the start of the study, then again after 6 weeks, to see if the participants’ immune system is stronger after taking the supplement.
What are the possible benefits and risks of participating?
The results of this study could lead to beta-glucan-enriched foods being used to improve the health of preschool children.
Where is the study run from?
Childcare Foundation - Medellin (Fundación de Atención a la Niñez (FAN) - Medellin) (Colombia)
When is the study starting and how long is it expected to run for?
July 2014 to January 2015
Who is funding the study?
1. Progal-BT SAS (Colombia)
2. iNNpulsa (Colombia)
Who is the main contact?
1. Dr S Urrego (public)
surregor@progal-bt.com
2. Dr E Higuita (scientific)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Edwin Higuita
ORCID ID
Contact details
Calle 51 # 51-27
Corporación Universitaria Remington
Facultad de Ciencias de la Salud
Medellin
050010374
Colombia
Type
Public
Additional contact
Dr Sergio Urrego
ORCID ID
Contact details
Calle 25 #65D 53
Medellín
050024074
Colombia
+54 4442060
surregor@progal-bt.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IN34-2014
Study information
Scientific title
Evaluation of changes in T cells subpopulations and NK (natural killer) cells in children aged 3 to 5 during a 6 week intervention with a nutritional complement enriched with biotechnologically Ganoderma lucidum extracted beta glucans
Acronym
Study hypothesis
A six weeks intervention with a nutritional complement enriched with beta glucans increases the T lymphocytes subpopulations and NK cells in 3 to 5 year old children.
Ethics approval
Ethics and Research Board of IPS Universitaria, University of Antioquia (Universidad de Antioquia), 26/11/2014, ref: 076.
Study design
Interventional open study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Schools
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Improvement in the baseline levels of immune system components in children.
Intervention
Participants receive a nutritional supplement in a maltodextrin matrix, enriched with beta-glucans extracted biotechnologically from Ganoderma lucidum. The supplement is taken 5 days per week, over 6 weeks.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Measured in blood sample at baseline then 6 weeks after intervention:
1. CD4+ and CD8+ T lymphocytes counts, measured by flow cytometry in whole blood collected.
2. NK cell counts, measured by flow cytometry (CD16+/CD56+).
Secondary outcome measures
1. Hemoleucogram measured by flow cytometry
2. Serum IgA measured by immunoturbidimetry
3. Nutritional and anthropometric measurements evaluated according to WHO guidelines and using WHO AnthroPlus software.
3.1. Weight/Height index
3.2. Height/Age index
3.3. Weight/Age index
Overall trial start date
01/07/2014
Overall trial end date
27/01/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged 3-5
2. Children attached to the Childcare Foundation - Medellin (Fundación de Atención a la Niñez (FAN) - Medellin)
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Children whose parents refuse to sign and accept the informed consent
2. Children outside of the General and Social Health Care System of Colombia
3. Use of corticosteroids or any other medical or pharmaceutical intervention
Recruitment start date
16/12/2014
Recruitment end date
04/01/2015
Locations
Countries of recruitment
Colombia
Trial participating centre
Childcare Foundation - Medellin (Fundación de Atención a la Niñez (FAN) - Medellin)
Medellin
-
Colombia
Sponsor information
Organisation
Progal-BT SAS
Sponsor details
Calle 25 65D-53
Medellin
00000
Colombia
(+574) 4442060
progalbt@progal-bt.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Progal-BT SAS (Colombia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
iNNpulsa (Colombia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list