none
Conditions
Interventions
Oral ingestion of the test beverage (200 mL) to the subject, once a day for 8 weeks.
Oral ingestion of the placebo beverage (200 mL) to the subject, once a day for 8 weeks.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Subjects who can give informed consent to participate in this trial after being provided with an explanation of the experimental protocol detail. 2) Healthy female subjects ranging in age from 40 to 60 at informed consent. 3) At a point of the screening test, subjects who realize that the subjects themselves are in a steady state of fatigue feeling. 4) Subjects ranging in BMI from not less than 18.6 to less than 30.0 kg/m2. 5) Subjects who have an irregular menstrual period with not less than a week, or who have been amenorrhea for no more than 5 years.
Exclusion criteria
Exclusion criteria: 1) Subjects with food allergy. 2) Subjects who have any difficulty in taking plant extract-containing foods (applicable to those who present symptoms of headache due to taste-related reasons and plant extract intakes). 3) Pregnant, possibly pregnant, or lactating subjects. 4) Subjects who have the habit of smoking, at the present time and/or within the past year before this trial. 5) Subjects with menopausal symptoms due to surgical treatments just like ovariectomy, and so on. 6) Subjects with serious or progressive chronic diseases/symptoms. 7) At a point of the screening test, subjects having infection history of COVID-19, and realizing that the subjects themselves are in the upward trend in fatigue feeling after the infection. 8) Subjects with a continuous remedy for chronic disease, accompanied by medication. 9) Subjects taking in the following foods that might affect menopausal symptoms; medicine (sleep inducers, antidepressants, antihypertensives, hormones, estrogen receptor-selective modulators for osteoporosis (SERMs), gynecological Chinese medicine), over-the-counter drugs (OTCs), health foods including health-specific/functional foods, with a frequency of no more than 5 days a week for over one month. 10) Subjects who took part in the other clinical/monitoring tests (limited to those involving oral intake or drug administration) within a month before giving informed consent to take part in this trial. 11) Others who have been determined as ineligible for participation in this trial, judging from the principal/sub investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Score on Chalder fatigue scale 2. Mood state on short version of POMS2 3. The autonomic nervous activity level (High Frequency, Low Frequency) 4. The autonomic nervous system balance (LF / HF ratio) | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed