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

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04728009
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Safety Issues	Dietary Supplement: Longan and lingzhi mushroom syrup	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Safety and Efficacy of Longan and Lingzhi Mushroom Syrup on Immune and Inflammatory Responses in Healthy Volunteers
• Actual Study Start Date: Feb 1, 2020
• Actual Primary Completion Date: May 15, 2020
• Actual Study Completion Date: May 15, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

1. Adverse effects on fasting blood glucose [12 weeks]

   Blood concentrations of fasting blood glucose (in mg/dL) were measured.

2. Adverse effects on long-term glycemic control [12 weeks]

   Blood concentrations of HbA1C (in %) were measured.

3. Adverse effects on hepatic function (1) [12 weeks]

   Blood concentrations of aspatate aminotransferase (AST) (in units/L) were measured.

4. Adverse effects on hepatic function (2) [12 weeks]

   Blood concentrations of alanine aminotransferase (ALT) (in units/L) were measured.

5. Adverse effects on hepatic function (3) [12 weeks]

   Blood concentrations of alkaline phosphatase (ALP) (in units/L) were measured.

6. Adverse effects on renal function (1) [12 weeks]

   Blood concentrations of blood urea nitrogen (in mg/dL) were measured.

7. Adverse effects on renal function (2) [12 weeks]

   Blood concentrations of serum creatinine (in mg/dL) were measured.

Secondary Outcome Measures

1. Effect on immune responses (1) [12 weeks]

   Blood concentrations of immunoglobulin (Ig) G (in mg/dL) were measured.

2. Effect on immune responses (2) [12 weeks]

   Blood concentrations of Ig M (in mg/dL) were measured.

3. Effect on immune responses (3) [12 weeks]

   Blood concentrations of Ig A (in mg/dL) were measured.

4. Effect on immune responses (4) [12 weeks]

   Blood concentrations of Ig E (in IU/mL) were measured.

5. Effect on inflammatory responses [12 weeks]

   Blood concentrations of C-reactive protein (in mg/L) were measured.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity	Bangkok		Thailand	10310

Sponsors and Collaborators

• Chulalongkorn University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT04728009
• Other Study ID Numbers: REH-62320
• First Posted: Jan 28, 2021
• Last Update Posted: Jan 28, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 28, 2021