Unique ID issued by UMIN | UMIN000027302 |
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Receipt number | R000031284 |
Scientific Title | Research on the effect of a lactic acid bacterium preparation for health conditions of females |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2021/05/18 09:58:11 |
Research on the effect of a lactic acid bacterium preparation for health conditions of females
Research on the effect of a lactic acid bacterium preparation for health conditions of females
Research on the effect of a lactic acid bacterium preparation for health conditions of females
Research on the effect of a lactic acid bacterium preparation for health conditions of females
Japan |
healthy adult females
Adult |
Others
NO
Verification of the effects of LAB-ingestion on mental and physical conditions of females
Efficacy
Evaluate the effects of LAB-ingestion on mental and physical conditions at 12 and 24 weeks after the start of intervention by questionnaires and related-measurement items
Autonomic nervous activity and abdominal symptom-related questionnaires and measurement items
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Daily intake of formulation including LAB for 24 weeks
Daily intake of placebo formulation without LAB for 24 weeks
18 | years-old | <= |
Not applicable |
Female
Subjects are without major problems in psychological and physical health.
1. Subjects having history of psychiatric or somatic diseases in the past and present.
2. Subjects taking medication at least for three months prior to the enrollment and during the experimental period.
80
1st name | |
Middle name | |
Last name | Kazuhito Rokutan |
Tokushima University
Dept. of Pathophysiology, Inst. of Biomedical Sciences
3-18-15 Kuramoto-cho, Tokushima
088-633-9004
rokutan@tokushima-u.ac.jp
1st name | |
Middle name | |
Last name | Kensei Nishida |
Tokushima University
Dept. of Pathophysiology, Inst. of Biomedical Sciences
3-18-15 Kuramoto-cho, Tokushima
088-633-9004
knishida@tokushima-u.ac.jp
Tokushima University
Asahi Group Holdings, Ltd.
Profit organization
NO
2017 | Year | 07 | Month | 01 | Day |
https://www.sciencedirect.com/science/article/pii/S175646462100075X
Published
https://www.sciencedirect.com/science/article/pii/S175646462100075X
83
Fifty-six women ingested CP2305 or placebo over the course of six menstrual cycles. The CP2305 group reported fewer psychological premenstrual symptoms. Water retention-related physical symptom scores were reduced in the placebo group. Significant differences were observed in the changes from baseline levels of salivary estradiol and progesterone between the two groups. CP2305 might improve the premenstrual symptoms of healthy young women in association with changes in reproductive hormone levels.
2021 | Year | 05 | Month | 18 | Day |
The participant inclusion criteria were as follows: (i) females aged 20-35 years, (ii) provided signed informed consent and agreed to participate in this study. The exclusion criteria were as follows: (i) currently on medication, (ii) menstrual cycle is generally of atypical length (shorter than 25 days or longer than 38 days), (iii) diagnosed with a mental disorder or scored above 60 on the self-rating depression scale (SDS).
Eighty-three female students were recruited at Tokushima University (Tokushima, Japan). Written informed consent was obtained from each participant. Of the 83 subjects, 8 were excluded due to medication (n=3) and abnormal length of menstrual cycle (n=5). The remaining 75 subjects were randomly allocated to either the CP2305 (n=37) or placebo group (n=38) with a stratified randomization for age. We excluded 19 subjects who failed to continue daily tablet ingestion, complete questionnaires, or provide salivary samples, with no statistical difference in drop-out numbers between the two groups (placebo, n=7; CP2305, n=12; x2 test, p-value 0.5507). The reasons provided for discontinuing the trial were: (i) difficulty in taking tablets daily (placebo, n=3; CP2305, n=4), (ii) difficulty keeping a weekly diary (placebo, n=2; CP2305, n=4) and (iii) unknown (placebo, n=2; CP2305, n=4). The final sample population comprised 25 subjects in the CP2305 group and 31 in the placebo group.
No adverse events were observed in any of the subjects, including those that dropped out, throughout the course of the trial.
The primary outcome was a change in the scale of the participants' psychological conditions during premenstrual period, which was evaluated using the PMTS-VAS questionnaire over time in the CP2305 group compared with the placebo group. The secondary outcomes were changes in the scale of the participants' physical conditions during the premenstrual period as assessed by an original VAS of luteal phase physical symptoms. In addition, changes in salivary hormone (cortisol, E2, and P4) and salivary chromogranin A (CgA) levels as the indicator for autonomic nervous activity, before and after administration in the CP2305 group, was compared to that of the placebo group.
Main results already published
2017 | Year | 06 | Month | 15 | Day |
2017 | Year | 06 | Month | 19 | Day |
2017 | Year | 07 | Month | 01 | Day |
2018 | Year | 06 | Month | 30 | Day |
2017 | Year | 05 | Month | 10 | Day |
2021 | Year | 05 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031284
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