Clinical trial NCT05443477: Hericium Erinaceus Mycelium and Probiotic of the Grape King Bio on Symptoms of Premenstrual Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: Premenstrual Syndrome
Hericium Erinaceus mycelium
probiotic
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 105
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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 placebo groups (n=35/group). Both subjects and researchers were blind to the treatment assignment until the statistical analysis was completed.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The differences from control of Daily record of severity of problems
timeFrame: 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.
measure: The changes from baseline of Daily record of severity of problems
timeFrame: 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 outcomes:
measure: The differences from control of high-sensitivity C-reactive protein
timeFrame: 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.
measure: The differences from baseline of high-sensitivity C-reactive protein
timeFrame: 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.
measure: The differences from control of high-sensitivity interleukin-6
timeFrame: 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.
measure: The differences from baseline of high-sensitivity interleukin-6
timeFrame: 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.
measure: The differences from control of high-sensitivity interleukin-1
timeFrame: 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.
measure: The differences from baseline of high-sensitivity interleukin-1
timeFrame: 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.
measure: The differences from control of high-sensitivity TNF-a
timeFrame: 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.
measure: The differences from baseline of high-sensitivity TNF-a
timeFrame: 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.
measure: The differences from control of total antioxidant capacity
timeFrame: 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.
measure: The differences from baseline of total antioxidant capacity
timeFrame: 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.
measure: The differences from control of malondialdehyde
timeFrame: 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.
measure: The differences from baseline of malondialdehyde
timeFrame: 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.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Kai-Li Liu
Study officials:
affiliation: Department of Nutrition, Chung Shan Medical University, Taichung, Taiwan
name: Kai-Li Liu, PhD
role: STUDY_CHAIR
affiliation: Department of Medicine, Chung Shan Medical University, Taichung, Taiwan
name: Man-Jung Hung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition, Chung Shan Medical University, Taichung, Taiwan
name: Yi-Chin Lin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Chung Shan Medical University, Taichung, Taiwan
name: Pey-Ling Shieh Shieh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.