Condition category
Not Applicable
Date applied
04/05/2015
Date assigned
22/05/2015
Last edited
17/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.progal-bt.com/

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

Publication citations

Additional files

Editorial Notes