Condition category
Not Applicable
Date applied
21/04/2015
Date assigned
14/05/2015
Last edited
17/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

www.progal-bt.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes