Mild Cognitive ImpairmentNCT06083350
Effects of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment
A study testing Yeast beta-glucan and Starch in people with Mild Cognitive Impairment and Alzheimer Disease, run by Xiaofan Xu at 2 sites in China.
Trial summary
Patients with mild cognitive impairment aged 50-80 years old were recruited in Shiyan City, Hubei Province, and divided into intervention group and placebo group. They were given yeast β-glucan capsules and starch capsules, respectively, for 6 months, in order to explore whether yeast β-glucan can improve cognitive… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Yeast beta-glucan and Starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesChina
- Study dates
- 27 Jun 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Aged 50-80 years;
- 2. Permanent residents of Shiyan City;
- 3. Meet the diagnostic criteria of MCI:
- 4. Willing to cooperate in completing questionnaire survey and clinical examination, and sign informed consent;
- 5. Did not participate in other clinical trials in the past 3 months.
Who cannot join
- 1. Alcohol or drug abuse;
- 2. Patients with neurological diseases that may cause cognitive dysfunction, including cerebrovascular diseases, stroke, brain tumors, Parkinson's disease, active epilepsy, etc.;
- 3. History of severe head trauma;
- 4. Severe sensory and perceptual impairment, unable to complete the cognitive function measurement;
- 5. History of mental illness such as depression, mania, anxiety, or take psychiatric drugs;
- 6. Serious heart, lung, liver, kidney dysfunction, malignant tumors, etc.;
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- 7. Suffering from autoimmune diseases;
- 8. Trauma, spinal injury or any disease that may affect the motor function of the limb;
- 9. Recent infectious diseases, acute gastrointestinal diseases;
- 10. Take antibiotics, probiotics, prebiotics or biostime products within the last 1 month.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Sinopharm Dongfeng General Hospital
Shiyan, Hubei, 442000
Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
Official title: A Randomized Controlled Trial of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment
Patients with mild cognitive impairment aged 50-80 years old were recruited in Shiyan City, Hubei Province, and divided into intervention group and placebo group. They were given yeast β-glucan capsules and starch capsules, respectively, for 6 months, in order to explore whether yeast β-glucan can improve cognitive function of patients with mild cognitive impairment by regulating gut microbiota and its metabolites.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- Yeast beta-glucan, Starch
- Keywords
- Mild Cognitive Impairment, Alzheimer Disease, Montreal Cognitive Assessment, Gut microbiota
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yeast beta-glucanDietary supplement
Produced by Angel Yeast Co., LTD
StarchDietary supplement
Produced by Angel Yeast Co., LTD
| Study group | Role | What they receive |
|---|---|---|
| Yeast beta-glucan | Experimental | Yeast beta-glucan capsules, 250mg，taken with meals, two capsules twice a day Receives: Dietary Supplement: Yeast beta-glucan |
| Starch | Placebo comparator | Starch capsule, 250mg, taken with meals, two capsules twice a day Receives: Dietary Supplement: Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment, MOCA
To assess overall cognitive function based on test scores. Patients with MOCA scores between 18 and 25 were included, and higher scores mean a better outcome.
Measured: up to 7 months
Secondary outcomes (8)
Gut microbiota, fecal SCFAs and SIgA
16S rRNA gene amplicon sequencing technique is used to determine species richness and diversity, species difference and functional prediction of gut microbiota; The content of SCFAs in fecal is determined by gas chromatography-mass spectrometry (GC-MS); Fecal SIgA is detected by enzyme-linked immunosorbent assay (ELISA).
Measured: up to 2 years
T/B/NK cells and IL-1β，IL-2，IL-4，IL-5，IL-6，IL-8，IL-10，IL-12p70，IL-17，IFN-γ and TNF-α in peripheral blood
The types and absolute counts of T/B/NK cells in peripheral blood are detected by flow cytometry, Plasma levels of IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-17, IFN-γ, and TNF-α are measured by Cytometric Bead Array (CBA) technology.
Measured: up to 7 months
Plasma Aβ-40, Aβ-42
The plasma levels of Aβ-40 and Aβ-42 were detected by ELISA
Measured: up to 2 years
Clock Drawing Test
To assess visual space and executive ability. Higher scores mean a better outcome.
Measured: up to 7 months
Digital Span Test
Attention and short-term memory are assessed by Digital Span Test. Higher scores mean a better outcome.
Measured: up to 7 months
Trail Making Test
To assess visual space and executive ability. The shorter the time, the lower the error rate, and the better the result.
Measured: up to 7 months
Verbal Fluency Test
To assess verbal fluency. Higher scores mean a better outcome.
Measured: up to 7 months
Digit Symbol Substitution Test
To assess reaction speed. Higher scores mean a better outcome.
Measured: up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start27 Jun 2023
- Primary completion5 Feb 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaofan Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaofan Xu, Huazhong University of Science and Technology
- Investigators
- Xiaofan Xu, Master, Principal investigator, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083350
- Sponsor's protocol ID
- HuazhongU-XXu
- Status last verified
- May 2024
- First submitted
- 26 Sep 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Yeast Beta-glucan on Cognitive Function in Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06083350
- Acronym / sponsor ID
- HuazhongU-XXu
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- Mild Cognitive Impairment, Alzheimer Disease, Montreal Cognitive Assessment, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Xiaofan XuUniversity, hospital or other
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with mild cognitive impairment aged 50-80 years old were recruited in Shiyan City, Hubei Province, and divided into intervention group and placebo group. They were given yeast β-glucan capsules and starch capsules, respectively, for 6 months, in order to explore whether yeast β-glucan can improve cognitive function of patients with mild cognitive impairment by regulating gut microbiota and its metabolites.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yeast beta-glucan | Experimental | Dietary Supplement: Yeast beta-glucanYeast beta-glucan capsules, 250mg，taken with meals, two capsules twice a day |
| Starch | Placebo comparator | Dietary Supplement: StarchStarch capsule, 250mg, taken with meals, two capsules twice a day |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Aged 50-80 years;
- 2. Permanent residents of Shiyan City;
- 3. Meet the diagnostic criteria of MCI:
- 4. Willing to cooperate in completing questionnaire survey and clinical examination, and sign informed consent;
- 5. Did not participate in other clinical trials in the past 3 months.
Key exclusion criteria (10 listed)
- 1. Alcohol or drug abuse;
- 2. Patients with neurological diseases that may cause cognitive dysfunction, including cerebrovascular diseases, stroke, brain tumors, Parkinson's disease, active epilepsy, etc.;
- 3. History of severe head trauma;
- 4. Severe sensory and perceptual impairment, unable to complete the cognitive function measurement;
- 5. History of mental illness such as depression, mania, anxiety, or take psychiatric drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yeast beta-glucanProduced by Angel Yeast Co., LTD | Dietary supplement | Yeast beta-glucan |
| StarchProduced by Angel Yeast Co., LTD | Dietary supplement | Starch |
Primary outcome
Montreal Cognitive Assessment, MOCA
Time frame: up to 7 months
To assess overall cognitive function based on test scores. Patients with MOCA scores between 18 and 25 were included, and higher scores mean a better outcome.
8 secondary outcomes
Gut microbiota, fecal SCFAs and SIgA
Time frame: up to 2 years
T/B/NK cells and IL-1β，IL-2，IL-4，IL-5，IL-6，IL-8，IL-10，IL-12p70，IL-17，IFN-γ and TNF-α in peripheral blood
Time frame: up to 7 months
Plasma Aβ-40, Aβ-42
Time frame: up to 2 years
Clock Drawing Test
Time frame: up to 7 months
Digital Span Test
Time frame: up to 7 months
Trail Making Test
Time frame: up to 7 months
Verbal Fluency Test
Time frame: up to 7 months
Digit Symbol Substitution Test
Time frame: up to 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaofan Xu, Master principal investigator
School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yeast beta-glucan and Starch in people with Mild Cognitive Impairment and Alzheimer Disease, run by Xiaofan Xu at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment, MOCA (time frame: up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.