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 |
| Protocol serial number | N/A |
| Sponsors | EAFIT University, Progal-BT S.A.S, Colanta, EAFIT University |
| Funder | Colombian Institute for the Development of Science and Technology (Colciencias) |
- 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
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
Public
Progal-BT S.A.S
Calle 25 #65D 53
Medellín
050024074
Colombia
 ORCID ID |
0000-0003-0737-6249 |
|---|
Scientific
Uniremington
Facultad de Ciencias de la Salud
Calle 51 #51-27
Medellín
050010374
Colombia
| ORCID ID |
0000-0001-5302-6042 |
|---|
Scientific
Universidad de Antioquia
Facultad de Enfermería
Calle 64 # 53 - 09
Medellín
050010480
Colombia
| ORCID ID |
0000-0002-3563-1529 |
|---|
Scientific
Fedsalud
Carrera 43A #1S-100 Piso 20
Medellín
050022144
Colombia
| Phone | +57 4 444 32 18 |
|---|---|
| liderasistencial@fedsalud.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase II double-blind randomized placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. CD4+ and CD8+ T lymphocytes counts are measured using flow cytometry from blood samples at baseline and 12 weeks |
| Key secondary outcome measure(s) |
1. Hemoleucogram is measured using flow cytometry at baseline and 12 weeks |
| 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 | All |
| Target sample size at registration | 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
Medellín
050001009
Colombia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
