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

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN64202426
• Date of registration: 30/03/2016
• Prospective Registration: No
• Primary sponsor: EAFIT University
• Public title: Evaluation of the immune system in children aged 2 to 5 that receive yogurt enriched with beta glucans extracted from the fungus Ganoderma lucidum
• 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
• Date of first enrolment: 09/09/2015
• Target sample size: 160
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN64202426
• Study type: Interventional
• Study design: Phase II double-blind randomized placebo controlled trial (Prevention)

Countries of recruitment

Colombia

Contacts

• Name: Edwin Higuita

• Name: Sergio Urrego

Key inclusion & exclusion criteria

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

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Immune function
Not Applicable
Immune function

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Colanta

Progal-BT S.A.S