Evaluation of the immune system in older adults that receive a nutritional complement enriched with beta glucans extracted from the fungus Ganoderma lucidum

ISRCTN	ISRCTN53126301
DOI	https://doi.org/10.1186/ISRCTN53126301
Secondary identifying numbers	IN33-2014

Submission date: 04/05/2015
Registration date: 22/05/2015
Last edited: 17/07/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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)

Contact information

Dr Edwin Higuita
Scientific

Calle 51 # 51-27
Corporación Universitaria Remington
Facultad de Ciencias de la Salud
Medellin
050010374
Colombia

ORCID ID	0000-0001-5302-6042

Dr Sergio Urrego
Public

Calle 25 #65D 53
Medellín
050024074
Colombia

Phone	+54 4442060
Email	surregor@progal-bt.com

Study information

Study design	Interventional open study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	GP practice
Study type	Quality of life
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
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
Study objectives	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(s)	Ethics and Research Board of IPS Universitaria, University of Antioquia (Universidad de Antioquia), 26/11/2014, ref: 076.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/07/2014
Completion date	27/03/2015

Eligibility

Participant type(s)	Healthy volunteer
Age group	Senior
Sex	Both
Target number of participants	50
Key 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)).
Key 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
Date of first enrolment	16/12/2014
Date of final enrolment	05/03/2015

Locations

Countries of recruitment

Colombia

Study 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

Progal-BT SAS
Industry

Calle 25 No. 65 D-53
Medellin
00000
Colombia

Phone	(+574) 4442060
Email	progalbt@progal-bt.com
Website	http://www.progal-bt.com/
"ROR"	https://ror.org/037hmn502

Funders

Funder type

Industry

Progal-BT SAS (Colombia)

No information available

iNNpulsa (Colombia)

No information available

Results and Publications

Intention to publish date	14/06/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.
IPD sharing plan