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

Not Applicable

Completed

• Conditions: Safety Issues
• Interventions: Dietary Supplement: Longan and lingzhi mushroom syrup

• Registration Number: NCT04728009
• Lead Sponsor: Chulalongkorn University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2020-05-15
• Study Completion: 2020-05-15
• Study First Submitted: 2020-12-23
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-25
• Last Update Submitted: 2021-01-25
• Study First Posted: 2021-01-28
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
longan and lingzhi mushroom syrup	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity; 🇹🇭 Bangkok, Thailand