Safety and Efficacy of Longan and Lingzhi Mushroom Syrup on Immune and Inflammatory Responses in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Longan and Lingzhi Mushroom Syrup on Immune and Inflammatory Responses in Healthy Volunteers

Conditions
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Safety Issues

Intervention / Treatment
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* Dietary Supplement: Longan and lingzhi mushroom syrup


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: longan and lingzhi mushroom syrup<br>All participants (N = 8) were asked to consume 5 mL of longan and lingzhi mushroom syrup as a sweetener daily for 12 weeks. | Dietary Supplement: Longan and lingzhi mushroom syrup<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects on fasting blood glucose | Blood concentrations of fasting blood glucose (in mg/dL) were measured. | 12 weeks | 
| Adverse effects on long-term glycemic control | Blood concentrations of HbA1C (in %) were measured. | 12 weeks | 
| Adverse effects on hepatic function (1) | Blood concentrations of aspatate aminotransferase (AST) (in units/L) were measured. | 12 weeks | 
| Adverse effects on hepatic function (2) | Blood concentrations of alanine aminotransferase (ALT) (in units/L) were measured. | 12 weeks | 
| Adverse effects on hepatic function (3) | Blood concentrations of alkaline phosphatase (ALP) (in units/L) were measured. | 12 weeks | 
| Adverse effects on renal function (1) | Blood concentrations of blood urea nitrogen (in mg/dL) were measured. | 12 weeks | 
| Adverse effects on renal function (2) | Blood concentrations of serum creatinine (in mg/dL) were measured. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on immune responses (1) | Blood concentrations of immunoglobulin (Ig) G (in mg/dL) were measured. | 12 weeks | 
| Effect on immune responses (2) | Blood concentrations of Ig M (in mg/dL) were measured. | 12 weeks | 
| Effect on immune responses (3) | Blood concentrations of Ig A (in mg/dL) were measured. | 12 weeks | 
| Effect on immune responses (4) | Blood concentrations of Ig E (in IU/mL) were measured. | 12 weeks | 
| Effect on inflammatory responses | Blood concentrations of C-reactive protein (in mg/L) were measured. | 12 weeks |