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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN53126301 |
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Date of registration:
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22/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the immune system in older adults that receive a nutritional complement enriched with beta glucans extracted from the fungus Ganoderma lucidum
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Scientific title:
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Evaluation of changes in T cells subpopulations and NK (natural killer) cells in older adults during a 12 week intervention with a nutritional complement enriched with biotechnologically Ganoderma lucidum extracted beta glucans |
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Date of first enrolment:
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16/12/2014 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN53126301 |
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Study type:
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Interventional |
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Study design:
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Interventional open study (Quality of life)
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Phase:
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Countries of recruitment
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Colombia
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Contacts
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Name:
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Edwin
Higuita |
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Address:
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Calle 51 # 51-27
Corporación Universitaria Remington
Facultad de Ciencias de la Salud
050010374
Medellin
Colombia |
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Telephone:
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Email:
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Affiliation:
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Name:
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Sergio
Urrego |
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Address:
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Calle 25 #65D 53
050024074
Medellín
Colombia |
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Telephone:
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+54 4442060 |
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Email:
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surregor@progal-bt.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Adults aged 65-85 attached to the Elderly Welfare Center, San Bernardo - Berta Arias Foundation, Botero (FUNDARIAS) (Centro de Bienestar al Anciano San Bernardo, Fundación Berta Arias de Botero (FUNDARIAS)).
Exclusion criteria: 1. Refuse to sign and acept the informed consent
2. Not within the General and Social Health Care System of Colombia
3. Use of corticosteroids or any other medical or pharmaceutical intervention
4. Anticoagulant treatment, stent, valve replacement, history of stroke
5. Diabetes
6. Mental impairments
7. Malnutrition or malnutrition risk
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Improvement in the baseline levels of immune system components in older adults.
Not Applicable
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Intervention(s)
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Participants receive a nutritional supplement in a maltodextrin and polydextrose matrix, enriched with beta glucans extracted biotechnologically from Ganoderma lucidum for a 12 week period.
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Primary Outcome(s)
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Measured in blood sample at baseline then 12 weeks after intervention:
1. CD4+ and CD8+ T lymphocytes counts, measured by flow cytometry in whole blood collected
2. NK cells counts, measured by flow cytometry (CD16+/CD56+)
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Secondary Outcome(s)
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1. Haemoleucogram measured by flow cytometry
2. Serum IgA measured by immunoturbidimetry
3. Lipid profile measure by enzymatic colorimetric assay
4. Glucose levels measured by ultraviolet test
5. Nutritional and anthropometric measurements: body mass index (BMI)
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Secondary ID(s)
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IN33-2014
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Source(s) of Monetary Support
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Progal-BT SAS (Colombia), iNNpulsa (Colombia)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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