Safety IssuesNCT04728009
Safety and Efficacy of Longan and Lingzhi Mushroom Syrup on Immune and Inflammatory Responses in Healthy Volunteers
A study testing Longan and lingzhi mushroom syrup in people with Safety Issues, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study aimed to preliminarily determine safety and efficacy of longan and lingzhi mushroom syrup on immune and inflammatory responses. Apparently healthy Thai adults (N = 8) aged 18-60 years were recruited into a prospective, single-group study. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- Longan and lingzhi mushroom syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2020to 15 May 2020
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy adults at Mae Fah Luang University and Chulalongkorn University
- aged 18-60 years
- HbA1c < 7%
Who cannot join
- self-reported immunodeficiency diseases, autoimmune diseases, infectious diseases, diabetes, thyroid diseases, cancer, hepatic- and/or renal dysfunction, uncontrollable illnesses and life-threatening diseases
- being allergic to longan and lingzhi products
- taking medications, herbs, and diet supplements affecting immune system, inflammatory response, and blood glucose a month before study enrollment
- pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Bangkok, 10310
About this study
This study aimed to preliminarily determine safety and efficacy of longan and lingzhi mushroom syrup on immune and inflammatory responses. Apparently healthy Thai adults (N = 8) aged 18-60 years were recruited into a prospective, single-group study. All participants were assigned to consume 5 mL of longan and lingzhi mushroom syrup daily for 12 weeks. Blood concentrations of fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), BUN (blood urea nitrogen), creatinine (Cr), immunoglobulins (IgG, IgM, IgA, and IgE), and C-reactive protein (CRP) were measured at baseline (week 0), week 4, week 8, and week 12.
- Conditions
- Safety Issues
- Being tested
- Longan and lingzhi mushroom syrup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longan and lingzhi mushroom syrupDietary supplement
Fresh fruit pulps of longan were stewed in hot water until they softened. No sugar and additives were added. The pulps were removed by filtration in order to obtain concentrated longan juice. After that, spray-dried powder of lingzhi mushroom extract was dissolved in water in the ratio of 1:2. To make the finished product, 99 g of longan juice was mixed with 1 g of the lingzhi extract in water. The sugar content of the syrup was 77 degrees Brix.
| Study group | Role | What they receive |
|---|---|---|
| longan and lingzhi mushroom syrup | Experimental | All participants (N = 8) were asked to consume 5 mL of longan and lingzhi mushroom syrup as a sweetener daily for 12 weeks. Receives: Dietary Supplement: Longan and lingzhi mushroom syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects on fasting blood glucose
Blood concentrations of fasting blood glucose (in mg/dL) were measured.
Measured: 12 weeks
Adverse effects on long-term glycemic control
Blood concentrations of HbA1C (in %) were measured.
Measured: 12 weeks
Adverse effects on hepatic function (1)
Blood concentrations of aspatate aminotransferase (AST) (in units/L) were measured.
Measured: 12 weeks
Adverse effects on hepatic function (2)
Blood concentrations of alanine aminotransferase (ALT) (in units/L) were measured.
Measured: 12 weeks
Adverse effects on hepatic function (3)
Blood concentrations of alkaline phosphatase (ALP) (in units/L) were measured.
Measured: 12 weeks
Adverse effects on renal function (1)
Blood concentrations of blood urea nitrogen (in mg/dL) were measured.
Measured: 12 weeks
Adverse effects on renal function (2)
Blood concentrations of serum creatinine (in mg/dL) were measured.
Measured: 12 weeks
Secondary outcomes (5)
Effect on immune responses (1)
Blood concentrations of immunoglobulin (Ig) G (in mg/dL) were measured.
Measured: 12 weeks
Effect on immune responses (2)
Blood concentrations of Ig M (in mg/dL) were measured.
Measured: 12 weeks
Effect on immune responses (3)
Blood concentrations of Ig A (in mg/dL) were measured.
Measured: 12 weeks
Effect on immune responses (4)
Blood concentrations of Ig E (in IU/mL) were measured.
Measured: 12 weeks
Effect on inflammatory responses
Blood concentrations of C-reactive protein (in mg/L) were measured.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Feb 2020
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728009
- Sponsor's protocol ID
- REH-62320
- Status last verified
- Jan 2021
- First submitted
- 23 Dec 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Longan and Lingzhi Mushroom Syrup on Immune and Inflammatory Responses in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04728009
- Acronym / sponsor ID
- REH-62320
- Conditions
- Safety Issues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 28 Jan 2021 (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.
This study aimed to preliminarily determine safety and efficacy of longan and lingzhi mushroom syrup on immune and inflammatory responses. Apparently healthy Thai adults (N = 8) aged 18-60 years were recruited into a prospective, single-group study. All participants were assigned to consume 5 mL of longan and lingzhi mushroom syrup daily for 12 weeks. Blood concentrations of fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), BUN (blood urea nitrogen), creatinine (Cr), immunoglobulins (IgG, IgM, IgA, and IgE), and C-reactive protein (CRP) were measured at baseline (week 0), week 4, week 8, and week 12.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| longan and lingzhi mushroom syrup | Experimental | Dietary Supplement: Longan and lingzhi mushroom syrupAll participants (N = 8) were asked to consume 5 mL of longan and lingzhi mushroom syrup as a sweetener daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Apparently healthy adults at Mae Fah Luang University and Chulalongkorn University
- aged 18-60 years
- HbA1c < 7%
Key exclusion criteria (4 listed)
- self-reported immunodeficiency diseases, autoimmune diseases, infectious diseases, diabetes, thyroid diseases, cancer, hepatic- and/or renal dysfunction, uncontrollable illnesses and life-threatening diseases
- being allergic to longan and lingzhi products
- taking medications, herbs, and diet supplements affecting immune system, inflammatory response, and blood glucose a month before study enrollment
- pregnant and breastfeeding women
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 |
|---|---|---|
| Longan and lingzhi mushroom syrupFresh fruit pulps of longan were stewed in hot water until they softened. No sugar and additives were added. The pulps were removed by filtration in order to obtain concentrated longan juice. After that, spray-dried powder of lingzhi mushroom extract was dissolved in water in the ratio of 1:2. To make the finished product, 99 g of longan juice was mixed with 1 g of the lingzhi extract in water. The sugar content of the syrup was 77 degrees Brix. | Dietary supplement | longan and lingzhi mushroom syrup |
Primary outcome
Adverse effects on fasting blood glucose
Time frame: 12 weeks
Blood concentrations of fasting blood glucose (in mg/dL) were measured.
Adverse effects on long-term glycemic control
Time frame: 12 weeks
Blood concentrations of HbA1C (in %) were measured.
Adverse effects on hepatic function (1)
Time frame: 12 weeks
Blood concentrations of aspatate aminotransferase (AST) (in units/L) were measured.
Adverse effects on hepatic function (2)
Time frame: 12 weeks
Blood concentrations of alanine aminotransferase (ALT) (in units/L) were measured.
Adverse effects on hepatic function (3)
Time frame: 12 weeks
Blood concentrations of alkaline phosphatase (ALP) (in units/L) were measured.
Adverse effects on renal function (1)
Time frame: 12 weeks
Blood concentrations of blood urea nitrogen (in mg/dL) were measured.
Adverse effects on renal function (2)
Time frame: 12 weeks
Blood concentrations of serum creatinine (in mg/dL) were measured.
5 secondary outcomes
Effect on immune responses (1)
Time frame: 12 weeks
Effect on immune responses (2)
Time frame: 12 weeks
Effect on immune responses (3)
Time frame: 12 weeks
Effect on immune responses (4)
Time frame: 12 weeks
Effect on inflammatory responses
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Longan and lingzhi mushroom syrup in people with Safety Issues, run by Chulalongkorn University at 1 site in Thailand.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse effects on fasting blood glucose (time frame: 12 weeks). The study lists 7 primary outcomes in all. 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 28 Jan 2021.