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. As people age, their immune systems weaken, meaning it becomes harder for older people to fight off infections such as the common cold. One way older adults can boost their immune system is to take food supplements that have extra ingredients designed to strengthen the immune system. A common ingredient used in 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 older adults.
Who can participate?
Healthy adults aged 65-85 attached to the Care Center for Older Adults (Colombia).
What does the study involve?
Participants are given a nutritional supplement with added beta-glucan to take 5 days a week for 12 weeks. Blood tests are carried out at the start of the study, then again after 12 weeks, to see if the participants’ immune system is stronger after taking the supplement.
What are the possible benefits and risks of participating?
Based on the results of previous studies, some possible benefits of participation include improvement of nutritional status evaluated by anthropometric measures, addition to daily diet, immune stimulation and potentiation, and cholesterol biosynthesis control. Risks associated with participation in this study include diarrhoea, vomiting and gastrointestinal discomfort during first days of intervention. Fullness and increased serum glucose (controlled by exclusion of diabetic and elevated serum glucose patients) is also a potential risk.
Where is the study run from?
Elderly Welfare Center, San Bernardo - Berta Arias Foundation, Botero (FUNDARIAS) (Centro de Bienestar del Anciano San Bernardo, Fundación Berta Arias de Botero (FUNDARIAS)) (Colombia)
When is the study starting and how long is it expected to run for?
July 2014 to March 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
http://orcid.org/0000-0001-5302-6042
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
IN33-2014
Study information
Scientific title
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
Acronym
Study hypothesis
A 12 week intervention with a nutritional complement enriched with beta glucans increases the T lymphocytes subpopulations and NK cells in older adults.
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
GP practices
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 older adults.
Intervention
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.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
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+)
Secondary outcome measures
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)
Overall trial start date
01/07/2014
Overall trial end date
27/03/2015
Reason abandoned
Eligibility
Participant 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)).
Participant type
Healthy volunteer
Age group
Senior
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
16/12/2014
Recruitment end date
05/03/2015
Locations
Countries of recruitment
Colombia
Trial participating centre
Elderly Welfare Center, San Bernardo - Berta Arias Foundation, Botero (FUNDARIAS) (Centro de Bienestar al Anciano San Bernardo, Fundación Berta Arias de Botero (FUNDARIAS))
Anexo 109 La Estrella
Antioquia
-
Colombia
Sponsor information
Organisation
Progal-BT SAS
Sponsor details
Calle 25 No. 65 D-53
Medellin
00000
Colombia
(+574) 4442060
progalbt@progal-bt.com
Sponsor type
Industry
Website
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 date, this study is in the phase of analysis of results and preparation of final manuscript. We hope to submit our manuscript in mid-June 2015.
Intention to publish date
14/06/2015
Participant level data
Available on request
Results - basic reporting
Publication summary