- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04728009
Safety and Efficacy of Longan and Lingzhi Mushroom Syrup on Immune and Inflammatory Responses in Healthy Volunteers
January 25, 2021 updated by: Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bangkok, Thailand, 10310
- Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Apparently healthy adults at Mae Fah Luang University and Chulalongkorn University
- aged 18-60 years
- HbA1c < 7%
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: longan and lingzhi mushroom syrup
All participants (N = 8) were asked to consume 5 mL of longan and lingzhi mushroom syrup as a sweetener daily for 12 weeks.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse effects on fasting blood glucose
Time Frame: 12 weeks
|
Blood concentrations of fasting blood glucose (in mg/dL) were measured.
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12 weeks
|
Adverse effects on long-term glycemic control
Time Frame: 12 weeks
|
Blood concentrations of HbA1C (in %) were measured.
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12 weeks
|
Adverse effects on hepatic function (1)
Time Frame: 12 weeks
|
Blood concentrations of aspatate aminotransferase (AST) (in units/L) were measured.
|
12 weeks
|
Adverse effects on hepatic function (2)
Time Frame: 12 weeks
|
Blood concentrations of alanine aminotransferase (ALT) (in units/L) were measured.
|
12 weeks
|
Adverse effects on hepatic function (3)
Time Frame: 12 weeks
|
Blood concentrations of alkaline phosphatase (ALP) (in units/L) were measured.
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12 weeks
|
Adverse effects on renal function (1)
Time Frame: 12 weeks
|
Blood concentrations of blood urea nitrogen (in mg/dL) were measured.
|
12 weeks
|
Adverse effects on renal function (2)
Time Frame: 12 weeks
|
Blood concentrations of serum creatinine (in mg/dL) were measured.
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect on immune responses (1)
Time Frame: 12 weeks
|
Blood concentrations of immunoglobulin (Ig) G (in mg/dL) were measured.
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12 weeks
|
Effect on immune responses (2)
Time Frame: 12 weeks
|
Blood concentrations of Ig M (in mg/dL) were measured.
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12 weeks
|
Effect on immune responses (3)
Time Frame: 12 weeks
|
Blood concentrations of Ig A (in mg/dL) were measured.
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12 weeks
|
Effect on immune responses (4)
Time Frame: 12 weeks
|
Blood concentrations of Ig E (in IU/mL) were measured.
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12 weeks
|
Effect on inflammatory responses
Time Frame: 12 weeks
|
Blood concentrations of C-reactive protein (in mg/L) were measured.
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12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2020
Primary Completion (Actual)
May 15, 2020
Study Completion (Actual)
May 15, 2020
Study Registration Dates
First Submitted
December 23, 2020
First Submitted That Met QC Criteria
January 25, 2021
First Posted (Actual)
January 28, 2021
Study Record Updates
Last Update Posted (Actual)
January 28, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- REH-62320
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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