Plain English Summary
Background and study aims
The immune system is a network of cells, tissues and organs which work to protect the body from infection. It takes time for the immune system to fully develop, and so children under five are more vulnerable to infections such as diarrhea and the common cold. Beta glucans are sugars found in bacteria, fungi and plants. For many years, they have been used to help boost the immune system in people whose natural defenses have been weakened due to disease or aggressive treatment, such as chemotherapy. It has been suggested that adding beta glucans to food could help to strengthen the immune system of young children. The aim of this study is to find out whether enriching yogurt with beta glucans from Ganoderma lucidum (a type of fungus) can help to strengthen the immune system of two to five year olds.
Who can participate?
Healthy children aged between two and five who are attached to the Childcare Foundation in Medellin Columbia).
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given a normal yogurt to eat five days a week (Monday-Friday) for 12 weeks. Those in the second group are given a yogurt which contains added beta-glucan to eat five days a week (Monday-Friday) for 12 weeks. At the start of the study and then after 12 weeks, participants in both groups have a blood test, so that the levels of different immune cells can be measured in order to see whether their immune system is stronger.
What are the possible benefits and risks of participating?
There is a possibility that the participants that eat yogurts containing beta glucans could have a beneficial immune response. There are no notable risks involved with taking part in the study.
Where is the study run from?
Child Care Center, Lucila Jaramillo (Chile)
When is the study starting and how long is it expected to run for?
September 2015 to December 2015
Who is funding the study?
Colombian Institute for the Development of Science and Technology, Colciencias (Columbia)
Who is the main contact?
1. Dr Sergio Urrego (public)
2. Dr Edwin Higutia (scientific)
3. Dr Sandra Duque (scientific)
4. Dr Andrea Cano (scientific)
Trial website
Contact information
Type
Public
Primary contact
Dr Sergio Urrego
ORCID ID
http://orcid.org/0000-0003-0737-6249
Contact details
Progal-BT S.A.S
Calle 25 #65D 53
Medellín
050024074
Colombia
Type
Scientific
Additional contact
Dr Edwin Higuita
ORCID ID
http://orcid.org/0000-0001-5302-6042
Contact details
Uniremington
Facultad de Ciencias de la Salud
Calle 51 #51-27
Medellín
050010374
Colombia
Type
Scientific
Additional contact
Dr Sandra Duque
ORCID ID
http://orcid.org/0000-0002-3563-1529
Contact details
Universidad de Antioquia
Facultad de Enfermería
Calle 64 # 53 - 09
Medellín
050010480
Colombia
Type
Scientific
Additional contact
Dr Andrea Cano
ORCID ID
Contact details
Fedsalud
Carrera 43A #1S-100 Piso 20
Medellín
050022144
Colombia
+57 4 444 32 18
liderasistencial@fedsalud.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Evaluation of changes on CD4+, CD8 T cells and NK, cells in children aged 2 to 5 during a 12 week intervention with a yogurt enriched with Ganoderma lucidum beta-glucans obtained biotechnologically: A double-blind ramdomized placebo controlled phase II trial
Acronym
Study hypothesis
Consuming yogurt enriched with beta-glucans for 12 weeks increases the T lymphocytes sub-populations and NK cells in 2 to 5 year old children.
Ethics approval
Ethics and Research Board of IPS Universitaria, University of Antioquia (Universidad de Antioquia), 26/08/2015, ref: 086
Study design
Phase II double-blind randomized placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Immune function
Intervention
Participants are randomly allocated to either intervention groups (Placebo or beta-glucans).
Placebo group: Children consume a standard yogurt once daily, five days a week (Monday-Friday) for 12 weeks.
Beta-glucan group: Children consume a yogurt enriched with beta-glucans extracted biotechnologically from Ganoderma lucidum once daily, five days a week (Monday-Friday) for 12 weeks.
Participants in both groups provide blood samples at baseline and 12 weeks for immunomodulation assessments.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
1. CD4+ and CD8+ T lymphocytes counts are measured using flow cytometry from blood samples at baseline and 12 weeks
2. NK cell counts are measured using flow cytometry (CD16+/CD56+) from blood samples at baseline and 12 weeks
Secondary outcome measures
1. Hemoleucogram is measured using flow cytometry at baseline and 12 weeks
2. Serum IgA is measured by immunoturbidimetry at baseline and 12 weeks
3. Nutritional and anthropometric measurements evaluated according to WHO guidelines and using WHO AnthroPlus software at baseline and 12 weeks
3.1. Weight/Height index
3.2. Height/Age index
3.3. Weight/Age index
4. Th1/Th2 citokines profile in serum is measured using Cytometric Bead Array (CBA) at baseline and 12 weeks
Overall trial start date
04/09/2015
Overall trial end date
11/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged 2-5
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
160
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
4. Diabetes
Recruitment start date
09/09/2015
Recruitment end date
11/09/2015
Locations
Countries of recruitment
Colombia
Trial participating centre
Child Care Center, Lucila Jaramillo
Fundación de Atención a la niñez. Calle 104 #50A-11
Medellín
050001009
Colombia
Sponsor information
Organisation
EAFIT University
Sponsor details
Carrera 49 # 7 sur -50
Medellín
050022009
Colombia
+57 4 2619500 Ext 9643
contacto@eafit.edu.co
Sponsor type
University/education
Website
Organisation
Progal-BT S.A.S
Sponsor details
Calle 25 #65D 53
Medellín
050024074
Colombia
+57 4 4442068
progalbt@progal-bt.com
Sponsor type
Industry
Website
Organisation
Colanta
Sponsor details
Calle 74 #64 A-51
Medellín
050034112
Colombia
+57 4 4455555
contacto@colanta.com.co
Sponsor type
Industry
Website
Organisation
EAFIT University
Sponsor details
Sponsor type
Not defined
Website
Funders
Funder type
Research organisation
Funder name
Colombian Institute for the Development of Science and Technology (Colciencias)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of results in a peer reviewed journal.
Intention to publish date
01/07/2017
Participant level data
Available on request
Basic results (scientific)
Publication list