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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04728009
• Other study ID #: REH-62320
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: May 15, 2020

Study information

• Verified date: January 2021
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Apparently healthy adults at Mae Fah Luang University and Chulalongkorn University

2. aged 18-60 years

3. HbA1c < 7%

Exclusion Criteria:

1. self-reported immunodeficiency diseases, autoimmune diseases, infectious diseases, diabetes, thyroid diseases, cancer, hepatic- and/or renal dysfunction, uncontrollable illnesses and life-threatening diseases

2. being allergic to longan and lingzhi products

3. taking medications, herbs, and diet supplements affecting immune system, inflammatory response, and blood glucose a month before study enrollment

4. pregnant and breastfeeding women

Related Conditions & MeSH terms

• Safety Issues

Intervention

Dietary Supplement:
• Longan and lingzhi mushroom syrup
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.

Locations

Country	Name	City	State
Thailand	Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse effects on fasting blood glucose	Blood concentrations of fasting blood glucose (in mg/dL) were measured.	12 weeks
Primary	Adverse effects on long-term glycemic control	Blood concentrations of HbA1C (in %) were measured.	12 weeks
Primary	Adverse effects on hepatic function (1)	Blood concentrations of aspatate aminotransferase (AST) (in units/L) were measured.	12 weeks
Primary	Adverse effects on hepatic function (2)	Blood concentrations of alanine aminotransferase (ALT) (in units/L) were measured.	12 weeks
Primary	Adverse effects on hepatic function (3)	Blood concentrations of alkaline phosphatase (ALP) (in units/L) were measured.	12 weeks
Primary	Adverse effects on renal function (1)	Blood concentrations of blood urea nitrogen (in mg/dL) were measured.	12 weeks
Primary	Adverse effects on renal function (2)	Blood concentrations of serum creatinine (in mg/dL) were measured.	12 weeks
Secondary	Effect on immune responses (1)	Blood concentrations of immunoglobulin (Ig) G (in mg/dL) were measured.	12 weeks
Secondary	Effect on immune responses (2)	Blood concentrations of Ig M (in mg/dL) were measured.	12 weeks
Secondary	Effect on immune responses (3)	Blood concentrations of Ig A (in mg/dL) were measured.	12 weeks
Secondary	Effect on immune responses (4)	Blood concentrations of Ig E (in IU/mL) were measured.	12 weeks
Secondary	Effect on inflammatory responses	Blood concentrations of C-reactive protein (in mg/L) were measured.	12 weeks