Evaluation of the immune system in children aged 2 to 5 that receive yogurt enriched with beta glucans extracted from the fungus Ganoderma lucidum

ISRCTN	ISRCTN64202426
DOI	https://doi.org/10.1186/ISRCTN64202426
Secondary identifying numbers	N/A

Submission date: 07/03/2016
Registration date: 30/03/2016
Last edited: 29/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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)

Contact information

Dr Sergio Urrego
Public

Progal-BT S.A.S
Calle 25 #65D 53
Medellín
050024074
Colombia

ORCID ID	0000-0003-0737-6249

Dr Edwin Higuita
Scientific

Uniremington
Facultad de Ciencias de la Salud
Calle 51 #51-27
Medellín
050010374
Colombia

ORCID ID	0000-0001-5302-6042

Dr Sandra Duque
Scientific

Universidad de Antioquia
Facultad de Enfermería
Calle 64 # 53 - 09
Medellín
050010480
Colombia

ORCID ID	0000-0002-3563-1529

Dr Andrea Cano
Scientific

Fedsalud
Carrera 43A #1S-100 Piso 20
Medellín
050022144
Colombia

Phone	+57 4 444 32 18
Email	liderasistencial@fedsalud.com

Study information

Study design	Phase II double-blind randomized placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	School
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
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
Study objectives	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(s)	Ethics and Research Board of IPS Universitaria, University of Antioquia (Universidad de Antioquia), 26/08/2015, ref: 086
Health condition(s) or problem(s) studied	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
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 study start date	04/09/2015
Completion date	11/12/2015

Eligibility

Participant type(s)	Healthy volunteer
Age group	Child
Lower age limit	2 Years
Upper age limit	5 Years
Sex	Both
Target number of participants	160
Key inclusion criteria	1. Children aged 2-5 2. Children attached to the Childcare Foundation - Medellin (Fundación de Atención a la Niñez (FAN) - Medellin)
Key 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
Date of first enrolment	09/09/2015
Date of final enrolment	11/09/2015

Locations

Countries of recruitment

Colombia

Study participating centre

Child Care Center, Lucila Jaramillo

Fundación de Atención a la niñez. Calle 104 #50A-11
Medellín
050001009
Colombia

Sponsor information

EAFIT University
University/education

Carrera 49 # 7 sur -50
Medellín
050022009
Colombia

Phone	+57 4 2619500 Ext 9643
Email	contacto@eafit.edu.co
Website	http://www.eafit.edu.co/

Progal-BT S.A.S
Industry

Calle 25 #65D 53
Medellín
050024074
Colombia

Phone	+57 4 4442068
Email	progalbt@progal-bt.com
Website	http://www.progal-bt.com/

Colanta
Industry

Calle 74 #64 A-51
Medellín
050034112
Colombia

Phone	+57 4 4455555
Email	contacto@colanta.com.co
Website	www.colanta.com.co

EAFIT University
Not defined

Website	http://www.eafit.edu.co/Paginas/index.aspx
"ROR"	https://ror.org/03y3y9v44

Funders

Funder type

Research organisation

Colombian Institute for the Development of Science and Technology (Colciencias)

No information available

Results and Publications

Intention to publish date	01/07/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication of results in a peer reviewed journal.
IPD sharing plan