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

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

      • Bangkok, Thailand, 10310
        • Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity

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:

  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 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.
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.

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.
12 weeks
Adverse effects on long-term glycemic control
Time Frame: 12 weeks
Blood concentrations of HbA1C (in %) were measured.
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.
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.
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.
12 weeks
Effect on immune responses (2)
Time Frame: 12 weeks
Blood concentrations of Ig M (in mg/dL) were measured.
12 weeks
Effect on immune responses (3)
Time Frame: 12 weeks
Blood concentrations of Ig A (in mg/dL) were measured.
12 weeks
Effect on immune responses (4)
Time Frame: 12 weeks
Blood concentrations of Ig E (in IU/mL) were measured.
12 weeks
Effect on inflammatory responses
Time Frame: 12 weeks
Blood concentrations of C-reactive protein (in mg/L) were measured.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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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