Evaluation of the immune system in children aged 3 to 5 that receive a nutritional complement enriched with beta glucans extracted from the fungus Ganoderma lucidum
| ISRCTN | ISRCTN29923286 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29923286 |
| Secondary identifying numbers | IN34-2014 |
- Submission date
- 21/04/2015
- Registration date
- 14/05/2015
- Last edited
- 29/05/2020
- 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 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)
Contact information
Scientific
Calle 51 # 51-27
Corporación Universitaria Remington
Facultad de Ciencias de la Salud
Medellin
050010374
Colombia
Public
Calle 25 #65D 53
Medellín
050024074
Colombia
| Phone | +54 4442060 |
|---|---|
| surregor@progal-bt.com |
Study information
| Study design | Interventional open study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | School |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 |
| Study objectives | 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(s) | Ethics and Research Board of IPS Universitaria, University of Antioquia (Universidad de Antioquia), 26/11/2014, ref: 076. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2014 |
| Completion date | 27/01/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Children aged 3-5 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 |
| Date of first enrolment | 16/12/2014 |
| Date of final enrolment | 04/01/2015 |
Locations
Countries of recruitment
- Colombia
Study participating centre
-
Colombia
Sponsor information
Industry
Calle 25 65D-53
Medellin
00000
Colombia
| Phone | (+574) 4442060 |
|---|---|
| progalbt@progal-bt.com | |
| Website | www.progal-bt.com |
"ROR" |
https://ror.org/037hmn502 |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date. |
| IPD sharing plan |
Editorial Notes
29/05/2020: No publications found.
