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OpenTrials
Completed

NCT Number: NCT04728009

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

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.

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Key information

Conditions

Safety Issues

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bangkok, 10310, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Adverse effects on fasting blood glucose

    Time frame: 12 weeks

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

  2. Adverse effects on long-term glycemic control

    Time frame: 12 weeks

    Blood concentrations of HbA1C (in %) were measured.

  3. Adverse effects on hepatic function (1)

    Time frame: 12 weeks

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

  4. Adverse effects on hepatic function (2)

    Time frame: 12 weeks

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

  5. Adverse effects on hepatic function (3)

    Time frame: 12 weeks

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

  6. Adverse effects on renal function (1)

    Time frame: 12 weeks

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

  7. Adverse effects on renal function (2)

    Time frame: 12 weeks

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

Secondary outcomes

  1. Effect on immune responses (1)

    Time frame: 12 weeks

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

  2. Effect on immune responses (2)

    Time frame: 12 weeks

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

  3. Effect on immune responses (3)

    Time frame: 12 weeks

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

  4. Effect on immune responses (4)

    Time frame: 12 weeks

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

  5. Effect on inflammatory responses

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2021
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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