Exploratory study on effects of plant extract-containing beverages against variations in a menopausal women's physical conditio
- Conditions
- none
- Registration Number
- JPRN-UMIN000043966
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 60
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method