Effectiveness of low doses of yeast beta-glucan 1,3/1,6 in adults with moderate stress in fighting respiratory infections, reducing fatigue, boosting the immune system and improving digestive health
| ISRCTN | ISRCTN48336189 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48336189 |
| Secondary identifying numbers | UKM PPI/111/8/JEP-2023-211 |
- Submission date
- 11/07/2023
- Registration date
- 04/08/2023
- Last edited
- 27/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English Summary
Background and study aims
Beta-glucans derived from fungi and yeast are known for their immune-modulating effects. It has been asserted that yeast beta-glucan significantly improves the function of the immune system by activating macrophages, one of the primary defences of the immune system. Its benefits have been extensively studied globally among athletes, stressed women, elderly people, healthy adults and children. Upper respiratory tract infections are the most common form of infection in every age group worldwide and have a significant negative impact on productivity, healthcare spending, and the economy. Based on published studies, the application of yeast beta glucans was proven as a possible therapeutic and preventive approach in managing and preventing recurrent respiratory tract infections. Therefore, this study aims to evaluate the effectiveness of yeast beta-glucan 1,3/1,6 on fatigue, respiratory infection, immune markers and gut health among adults with moderate stress.
Who can participate?
People aged 18-59 years with moderate stress and common cold symptoms in the past 6 months
What does the study involve?
Participants are randomly allocated to take either Yeast Beta Glucan (YBG) dose 1, dose 2 or dose 3 or a placebo (a substance that has no effect, used as a control). The study duration is 12 weeks. In this study, several assessments will be conducted at the screening level, baseline, the sixth week and the twelfth week. Other assessments that will be conducted in this study include blood profile, gut microbiome analysis and diet recall. A total of 20ml of blood will be collected to conduct the complete blood count including immune and oxidative stress biomarkers. In addition, several questionnaire forms will be used to assess the occurrence of upper respiratory tract infection symptoms, mood status and fatigue. In addition, an anthropometric evaluation will be carried out to assess the nutritional status of the participants.
What are the possible benefits and risks of participating?
The benefits may not be direct. The supplement has the potential to strengthen and improve the immune system of the participants who receive this supplement. Participants may or may not experience side effects. Side effects may include changes in blood pressure, nausea, diarrhea and vomiting.
Where is the study run from?
Mead Johnson Nutrition (Malaysia)
When is the study starting and how long is it expected to run for?
January 2023 to September 2025
Who is funding the study?
Mead Johnson Nutrition (Malaysia) Educational Grant
Who is the main contact?
1. Prof. Dr Suzana Shahar, suzana.shahar@ukm.edu.my
2. Nur Nadia Mohamad Habibullah, P126613@siswa.ukm.edu.my
Contact information
Principal Investigator
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
| Phone | +60 (0)3 9289 7800/+60 (0)19332 6530 |
|---|---|
| suzana.shahar@ukm.edu.my |
Study information
| Study design | Multicenter interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Hospital, University/medical school/dental school, Workplace |
| Study type | Efficacy |
| Participant information sheet | PIS_43931.pdf |
| Scientific title | Efficacy of low dosage yeast beta-glucan 1,3/1,6 on respiratory infection, fatigue, immune markers and gut health among adults with moderate stress |
| Study hypothesis | 1. The yeast beta glucan 1,3/1,6 supplementation is effective in improving upper respiratory tract infection symptoms and its related immune responses among adults with moderate stress in Klang Valley. 2. The yeast beta glucan 1,3/1,6 supplementation is effective in improving fatigue and psychological aspects among adults with moderate stress in Klang Valley. 3. The yeast beta glucan 1,3/1,6 supplementation is effective in improving gut health among adults with moderate stress in Klang Valley. |
| Ethics approval(s) |
Approved 22/06/2023, Research Ethics Committee, The National University of Malaysia (Sekretariat Etika Penyelidikan Universiti Kebangsaan Malaysia, Tingkat 1, Blok Klinikal, Hospital Canselor Tuanku Mukhriz, Pusat Perubatan UKM, Jalan Yaacob Latif, Bandar Tun Razak 56000 Cheras, Kuala Lumpur, 56000, Malaysia; +60 (0)391455046; sepukm@ukm.edu.my), ref: UKM PPI/111/8/JEP-2023-211 |
| Condition | Respiratory infections, fatigue, immune system, and digestive health of adults with moderate stress |
| Intervention | Current interventions as of 30/01/2024: This is a randomized, double-blind, placebo-controlled study designed to determine the efficacy of Yeast Beta Glucan 1,3/1,6 on respiratory infection, fatigue, immune markers and gut health among adults for 12 weeks. This study requires participants to take either Yeast Beta Glucan (YBG) dose 1, YBG dose 2, YBG dose 3 or a placebo (a substance that has no therapeutic effect, used as a control). Once registered for the study, the eligible participants will undergo simple randomization to determine group allocation. In this study, several assessments will be conducted at the screening level, baseline, the sixth week and the twelfth week. Other assessments that will be conducted in this study include blood profile, gut microbiome analysis and 3-day diet record. A total of 20 ml of blood will be collected to conduct the complete blood count including immune and oxidative stress biomarkers. In addition, several questionnaire forms will be used to assess the occurrence of upper respiratory tract infection (URTI) symptoms, mood status and fatigue. In addition, an anthropometric evaluation will be made to assess the nutritional status of the study participant. Previous interventions: This is a randomized, double-blind, placebo-controlled study designed to determine the efficacy of Yeast Beta Glucan 1,3/1,6 on respiratory infection, fatigue, immune markers and gut health among adults for 3 months. The supplement is in a 60 g sachet known as Provital Immuna Plus® is a nutritious milk that helps to support a healthy immune system. Finished products in the form of 60 mg sachet registration number 20-1-03444. The subjects will be taking either 204 mg and 100 mg of Yeast Beta Glucan or placebo with 0 mg in the form of a 60 g sachet mixed with 160 ml of warm water until dissolved, two times daily (30 g each serving). The placebo which will be used is a sensory-identical supplement in a sachet, composed of 60 mg maltodextrin. Once registered for the study, the eligible participants will undergo simple randomization to determine group allocation. The study duration is 12 weeks. In this study, several assessments will be conducted at the screening level, the fourth week, the sixth week and the twelfth week. Other assessments that will be conducted in this study include blood profile, gut microbiome analysis and diet recall. A total of 20 ml of blood will be collected to conduct the complete blood count including immune and oxidative stress biomarkers. In addition, several questionnaire forms will be used to assess the occurrence of upper respiratory tract infection (URTI) symptoms, mood status and fatigue. In addition, an anthropometric evaluation will be made to assess the nutritional status of the study subjects. |
| Intervention type | Supplement |
| Primary outcome measure | Current primary outcome measure as of 22/01/2024: 1. Upper respiratory tract infection (URTI) episodes: occurrence, severity and duration measured using the Wisconsin Upper Respiratory Symptom Survey (WURSS)-21 at baseline, weeks 6 and 12. 2. Fatigue measured using the Profile of Mood State (POMS) at baseline and week 6 and 12. 3. Blood immune markers: cytokines interleukin: [IL] IL-6, IL 8, IL-10, TNF-interferon [IFN]-γ, inflammation - CRP measured using blood samples at baseline and week 12. 4. Biomarkers and oxidative stress: oxidative stress (MDA, LPO), inflammatory biomarkers (iNOS, Cox2) measured at baseline and week 12. 5. Quality of life measured using Short Form-36 (SF-36) at baseline and weeks 4, 6 and 12. ______ Previous primary outcome measure: 1. Basic health profile (BMI, waist circumference, body fat percentage, complete blood count, fasting blood sugar, lipid profile, liver function test, renal function test) at baseline and week 12 2. Upper respiratory tract infection (URTI) episodes: occurrence, severity and duration measured using the Wisconsin Upper Respiratory Symptom Survey (WURSS)-21 at baseline and weeks 4, 6 and 12 3. Blood immune markers: cytokines interleukin: [IL] IL-6, IL 8, IL-10, TNF-interferon [IFN]-γ, inflammation - CRP measured using blood samples at baseline and week 12 |
| Secondary outcome measures | Current secondary outcome measures as of 22/01/2024: 1.The gut bacterial diversity (α diversity, β diversity, comparative analysis) and predicted functional analysis will be assessed at baseline and week 12 _____ Previous secondary outcome measures: 1. Fatigue measured using the Profile of Mood State (POMS) at baseline and weeks 4, 6 and 12 2. Biomarkers and oxidative stress: oxidative stress (MDA, LPO), inflammatory biomarkers (iNOS, Cox2) measured at baseline and week 12 3. Quality of life measured using Short Form-36 (SF-36) at baseline and weeks 4, 6 and 12 4. Microbiome abundance and functional analysis (α diversity, β diversity, comparative analysis) at baseline and week 12 |
| Overall study start date | 01/01/2023 |
| Overall study end date | 30/09/2025 |
Eligibility
| Participant type(s) | Healthy volunteer, Health professional, Employee |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 59 Years |
| Sex | Both |
| Target number of participants | 200 |
| Participant inclusion criteria | Current inclusion criteria as of 16/01/2024: 1. 18-59 years old 2. In a stressful environment 3. Scoring 14-26 (moderate stress) on the Perceived Stress Scale (PSS-10) 4. Symptoms of common colds in the past 6 months 5. Willing to comply with protocol requirements Previous inclusion criteria: 1. 18-60 years old 2. In a stressful environment 3. Scoring 14-26 (moderate stress) on the Perceived Stress Scale (PSS-10) 4. Symptoms of common colds in the past 6 months 5. Willing to comply with protocol requirements |
| Participant exclusion criteria | 1. Participant on immunosuppressant (i.e., steroids) 2. Use of immune-modifying medications or dietary supplements affecting the immune system (at least 2 weeks of washing period for inclusion) 3. Any autoimmune or health concerns 4. Uncontrolled comorbidities including diabetes, hypertension, cardiovascular disease, chronic kidney disease, chronic liver disease, active malignancy, endocrine disorder and cancer 5. Uncontrolled chronic respiratory illness including allergic rhinitis or asthma, presence of nasal ulcers/polyps 6. Body temperature >38◦C at study commencement 7. Pregnant/lactating female 8. On specific dietary requirements (diabetic diet/low salt diet/etc) 9. On prebiotics or probiotics supplementation (at least 2 weeks of washing period for inclusion) 10. On antibiotics washing period within 2 weeks for inclusion 11. Disabilities individuals- long-term physical, mental, intellectual and sensory impairment 12. Individuals without symptoms of common colds for the past 6 months 13. Allergy to yeast, oat, wheat, barley 14. Influenza vaccination for the past 1 year 15. Pneumococcal vaccine for the past 5 years 16. Participate in another research study |
| Recruitment start date | 02/02/2024 |
| Recruitment end date | 30/11/2024 |
Locations
Countries of recruitment
- Malaysia
Study participating centres
Kuala Lumpur
50300
Malaysia
Hospital Canselor Tuanku Muhriz
Jalan Yaacob Latif, Bandar Tun Razak
Kuala Lumpur
56000
Malaysia
Jalan Yaacob Latif, Bandar Tun Razak
Kuala Lumpur
56000
Malaysia
Sponsor information
Industry
201, Jalan Tun Sambanthan, Brickfields
Kuala Lumpur
50470
Malaysia
| Phone | +60 (0)14 668 3620 |
|---|---|
| SoFie.Tan@reckitt.com | |
| Website | https://www.reckitt.com/ |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Mead Johnson
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 25/07/2023 | No | Yes | ||
| Protocol article | 20/01/2025 | 27/01/2025 | Yes | No |
Additional files
Editorial Notes
27/01/2025: Publication reference added.
10/09/2024: The following changes were made:
1. The recruitment end date was changed from 31/07/2024 to 30/11/2024.
2. The individual participant data (IPD) sharing plan and summary were added.
30/01/2024: The interventions were changed and the plain English summary was updated to reflect that change.
22/01/2024: The following changes were made to the trial record:
1. The primary outcome measure was changed.
2. The secondary outcome measures were changed.
16/01/2024: The following changes were made to the study record:
1. The overall study end date was changed from 31/12/2024 to 30/09/2025.
2. The recruitment start date was changed from 14/08/2023 to 02/02/2024.
3. The recruitment end date was changed from 01/06/2024 to 31/07/2024.
4. The inclusion criteria were updated.
25/07/2023: Study's existence confirmed by the Research Ethics Committee, The National University of Malaysia.
