Hericium Erinaceus Mycelium and Probiotic of the Grape King Bio on Symptoms of Premenstrual Syndrome

To Evaluate the Improvement Effect of Supplementing Hericium Erinaceus Mycelium Capsules and Grape King Probiotic Capsules of the Grape King Bio on Physiological and Psychological Symptoms of Premenstrual Syndrome

The purpose of this experiment is to evaluate the efficacy of supplemental health food Grape King Hericium erinaceus Mycelium Capsules and Grape King Probiotic Capsules in improving physical and psychological symptoms, blood oxidative stress and inflammation indicators in women with premenstrual syndrome.

Study Overview

• Status: Active, not recruiting
• Conditions: Premenstrual Syndrome
• Intervention / Treatment: Dietary supplement: Hericium Erinaceus Mycelium; Dietary supplement: Probiotic; Dietary supplement: control

Detailed Description

This study was a randomized, double-blinded and placebo-controlled research. This study was approved by the Institutional Review Board of the Chung Shan Medical University Hospital and all Participants signed the written informed consent to participate in the study.

Participants met the inclusion criteria, ie: age 20~45 yr and a regular menstrual cycle (21~35 days per cycle) were recruited through advertisements posted around the Chun Shan Medical university campus. In screening phase of this study, affective and one somatic symptom in before onset of menstruation in two consecutive cycles and was not affected by depression or anxiety disorder, she is examined by the Attending Physician of the Obstetrics and Gynecology Department to diagnosed a patient with premenstrual syndrome. In the intervention phase of this study, 105 eligible participant were randomly divided into intervention (Grape King Hericium erinaceus Mycelium Capsules and Grape King Probiotic Capsules) and control groups (n=35/group). Both subjects and researchers were blind to the treatment assignment until the statistical analysis was completed. All participants received two oral capsules containing Hericium erinaceus Mycelium, probiotics or placebo every day for the 3 months. The capsules of intervention supplementations and placebo provided by Grape King Biotechnology Inc in identical appearance and package to guarantee the blindness.

Data collection A validated semi-quantitative Food Frequency Questionnaire was used to obtain daily nutritional values of participants. To assess the symptoms of PMS, all subjects need to fill out daily record of severity of problems on a daily basis in the 3 months of intervention period and 6 months after the intervention. In the 0, 1, 3 months of intervention, the anthropometric parameters and body composition were measured by using bioelectrical impedance analysis method ( MC-980 MA PLUS, TANITA BIA Technology). In the 0, 1, 3 months of intervention, venous blood samples were taken from all subjects for measuring the marks of oxidative stress and inflammation.

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Kai-Li Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women aged 20-45
2. The menstrual cycle is 21~35 days/time
3. PMS diagnosed by an obstetrician
4. Willing to sign the subject's consent form

Exclusion Criteria:

1. Those are with cancer, cardiovascular, kidney, liver, infectious and endocrine diseases, aw well as with depression and anxiety tendencies
2. Those have a surgery in the last 6 months
3. Those use of probiotics, estrogen and birth control pills
4. Body mass index > 39 kg/m2, smoking, drinking
5. Death of a close relative and other stressful events within the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hericium Erinaceus Mycelium; patients with premenstrual syndrome received supplementation of Hericium Erinaceus Mycelium capsules	Dietary supplement: Hericium Erinaceus Mycelium; participants received two oral capsules containing Hericium erinaceus Mycelium every day for the 3 months.
Experimental: Probiotic; patients with premenstrual syndrome received supplementation of Probiotic capsules	Dietary supplement: Probiotic; participants received two oral capsules containing Probiotic powder every day for the 3 months.
Placebo Comparator: control; patients with premenstrual syndrome received supplementation of placebo capsules	Dietary supplement: control; participants received two oral capsules containing control powder every day for the 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The differences from control of Daily record of severity of problems	This questionnaire of daily record of severity of problems were using to determine the severity of PMS including mood, physical and behavioral symptoms and characteristics. There are21 items grouped into 11 domains. Additional questions asked about quality of life and satisfaction of self-health. The levels of severity on this form are: 1- Not at all, 2- Minimal to Mild, 3-Moderate, 4- Severe. During each month of the intervention period and the 3rd menstrual cycles at the end of intervention, the differences of the total scores of menstrual cycles compared with the control group in each intervention groups were analyzed.	All eligible subjects recorded their symptoms by questionnaire of daily record of severity of problems at every day of 3 consecutive menstrual cycles during the intervention period and the 3rd menstrual cycles at the end of intervention.
The changes from baseline of Daily record of severity of problems	This questionnaire of daily record of severity of problems were using to determine the severity of PMS including mood, physical and behavioral symptoms and characteristics. There are21 items grouped into 11 domains. Additional questions asked about quality of life and satisfaction of self-health. The levels of severity on this form are: 1- Not at all, 2- Minimal to Mild, 3-Moderate, 4- Severe. During each month of the intervention period and the 3rd menstrual cycles at the end of intervention, the changes of the total scores of menstrual cycles compared with the baseline in each groups were analyzed.	All eligible subjects recorded their symptoms by questionnaire of daily record of severity of problems at every day of 3 consecutive menstrual cycles during the intervention period and the 3rd menstrual cycles at the end of intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The differences from control of high-sensitivity C-reactive protein	The inflammation marker, high-sensitivity C-reactive protein (mg/L), in the blood of the subjects were measured. The different concentration of the high-sensitivity C-reactive protein at each time points of intervention groups compared with control group were analyzed.	In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of high-sensitivity C-reactive protein.
The differences from baseline of high-sensitivity C-reactive protein	The inflammation marker, high-sensitivity C-reactive protein (mg/L), in the blood of the subjects were measured. The different concentration of the high-sensitivity C-reactive proteinat at the 1st and 3rd month compared with baseline in each group were analyzed.	In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of high-sensitivity C-reactive protein.
The differences from control of high-sensitivity interleukin-6	The inflammation marker, interleukin-6 (pg/mL), in the blood of the subjects were measured. The different concentration of the interleukin-6 at each time points of intervention groups compared with control group were analyzed.	In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of interleukin-6.
The differences from baseline of high-sensitivity interleukin-6	The inflammation marker, interleukin-6 (pg/mL), in the blood of the subjects were measured. The different concentration of the interleukin-6 at the 1st and 3rd month compared with baseline in each group were analyzed.	In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of interleukin-6.
The differences from control of high-sensitivity interleukin-1	The inflammation marker, interleukin-1 (pg/mL), in the blood of the subjects were measured. The different concentration of the interleukin-1 at each time points of intervention groups compared with control group were analyzed.	In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of interleukin-1.
The differences from baseline of high-sensitivity interleukin-1	The inflammation marker, interleukin-1 (pg/mL), in the blood of the subjects were measured. The different concentration of the interleukin-1 at the 1st and 3rd month compared with baseline in each group were analyzed.	In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of interleukin-1.
The differences from control of high-sensitivity TNF-a	The inflammation marker, TNF-a (pg/mL), in the blood of the subjects were measured. The different concentration of the TNF-a at each time points of intervention groups compared with control group were analyzed.	In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of TNF-a.
The differences from baseline of high-sensitivity TNF-a	The inflammation marker, TNF-a (pg/mL), in the blood of the subjects were measured. The different concentration of the TNF-a at the 1st and 3rd month compared with baseline in each group were analyzed.	In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of TNF-a.
The differences from control of total antioxidant capacity	The oxidative stress index, total antioxidant capacity (μmol/L), in the blood of the subjects were measured. The different concentration of the total antioxidant capacity at each time points of intervention groups compared with control group were analyzed.	In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of total antioxidant capacity.
The differences from baseline of total antioxidant capacity	The oxidative stress index, total antioxidant capacity (μmol/L), in the blood of the subjects were measured. The different concentration of the total antioxidant capacity at the 1st and 3rd month compared with baseline in each group were analyzed.	In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of total antioxidant capacity.
The differences from control of malondialdehyde	The oxidative stress index, malondialdehyde (nmol/mL), in the blood of the subjects were measured. The different concentration of the total antioxidant capacity at each time points of intervention groups compared with control group were analyzed.	In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of malondialdehyde.
The differences from baseline of malondialdehyde	The oxidative stress index, malondialdehyde (nmol/mL), in the blood of the subjects were measured. The different concentration of the total antioxidant capacity at the 1st and 3rd month compared with baseline in each group were analyzed.	In the 1st data of menstruation of the beginning, 1st and 3rd months of intervention, the blood of all eligible subjects were collected to measure the concentration of malondialdehyde.

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Investigators: Study Chair: Kai-Li Liu, PhD, Department of Nutrition, Chung Shan Medical University, Taichung, Taiwan; Principal Investigator: Man-Jung Hung, MD, PhD, Department of Medicine, Chung Shan Medical University, Taichung, Taiwan; Principal Investigator: Yi-Chin Lin, PhD, Department of Nutrition, Chung Shan Medical University, Taichung, Taiwan; Principal Investigator: Pey-Ling Shieh Shieh, PhD, Department of Psychology, Chung Shan Medical University, Taichung, Taiwan

Publications and helpful links

General Publications

• Duvan CI, Cumaoglu A, Turhan NO, Karasu C, Kafali H. Oxidant/antioxidant status in premenstrual syndrome. Arch Gynecol Obstet. 2011 Feb;283(2):299-304. doi: 10.1007/s00404-009-1347-y. Epub 2010 Jan 19.
• Danis P, Drew A, Lingow S, Kurz S. Evidence-based tools for premenstrual disorders. J Fam Pract. 2020 Jan/Feb;69(1):E9-E17. No abstract available.
• Endicott J, Nee J, Harrison W. Daily Record of Severity of Problems (DRSP): reliability and validity. Arch Womens Ment Health. 2006 Jan;9(1):41-9. doi: 10.1007/s00737-005-0103-y. Epub 2005 Sep 20.
• Sharifi-Rad J, Rodrigues CF, Stojanovic-Radic Z, Dimitrijevic M, Aleksic A, Neffe-Skocinska K, Zielinska D, Kolozyn-Krajewska D, Salehi B, Milton Prabu S, Schutz F, Docea AO, Martins N, Calina D. Probiotics: Versatile Bioactive Components in Promoting Human Health. Medicina (Kaunas). 2020 Aug 27;56(9):433. doi: 10.3390/medicina56090433.
• Nagano M, Shimizu K, Kondo R, Hayashi C, Sato D, Kitagawa K, Ohnuki K. Reduction of depression and anxiety by 4 weeks Hericium erinaceus intake. Biomed Res. 2010 Aug;31(4):231-7. doi: 10.2220/biomedres.31.231.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Anticipated): January 7, 2023
• Study Completion (Anticipated): January 7, 2023

Study Registration Dates

• First Submitted: June 12, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: probiotic; Premenstrual Syndrome; Hericium Erinaceus mycelium
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Menstruation Disturbances; Syndrome; Premenstrual Syndrome
• Other Study ID Numbers: CS2-20104; BR-CT004 (Other Grant/Funding Number: Grape King Bio)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No