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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN29923286
Enrollment
50
Registered
2015-05-14
Start date
2014-12-16
Completion date
Unknown
Last updated
2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improvement in the baseline levels of immune system components in children. Not Applicable

Interventions

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

Sponsors

Progal-BT SAS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged 3-5 2. Children attached to the Childcare Foundation - Medellin (Fundación de Atención a la Niñez (FAN) - Medellin)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Colombia

Contacts

Public ContactSergio Urrego
surregor@progal-bt.com+54 4442060

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026