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

NCT04728009 | Completed

• 1 other identifier: REH-62320
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Effect on immune responses (1)

  12 weeks

• Effect on immune responses (2)

  12 weeks

• Effect on immune responses (3)

  12 weeks

• Effect on immune responses (4)

  12 weeks

• Effect on inflammatory responses

  12 weeks

Study Arms (1)

longan and lingzhi mushroom syrup

EXPERIMENTAL

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

Interventions

Longan and lingzhi mushroom syrup DIETARY_SUPPLEMENT

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.

longan and lingzhi mushroom syrup

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Apparently healthy adults at Mae Fah Luang University and Chulalongkorn University
• aged 18-60 years
• HbA1c \< 7%

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity

Bangkok, 10310, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 28, 2021
• Study Start: February 1, 2020
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

TH (1)