Tokyo, July 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062300) titled 'A Study on the Effects of Continuous Intake of the Test Food on sleep quality in menopausal women' on July 22.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Macromill Carenet, Inc.
Condition:
Condition - Healthy participants
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of 12-week continuous intake of the test food on sleep quality in healthy Japanese women aged 40 to 64 years who are dissatisfied with their sleep quality through a randomized, double-blind, placebo-controlled, parallel-group study.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Continuous intake of the test food for 12 weeks
Interventions/Control_2 - Continuous intake of the placebo food for 12 weeks
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Female
Key inclusion criteria - (1) Healthy Japanese women aged 40 to 64 years.
(2) Individuals who had menstruation within the past 1 year and are irregular or less than 5 years postmenopausal.
(3) Individuals whose total score of Simplified Menopausal Index (SMI) is 50 or less.
(4) Individuals who are dissatisfied with their sleep quality.
(5) Individuals who feel temporary discomfort such as shoulder pain.
(6) Individuals who have received sufficient explanation regarding the purpose and contents of this study, have the capacity to consent, fully understand, volunteer of their own free will, and provide electronic informed consent.
(7) Individuals judged by the principal investigator to have no problems participating in the study based on the interview during the pre-observation period.
(8) Among those who meet the criteria (1) to (7) above and do not meet the exclusion criteria, those who have lower scores for sleep time in the OSA sleep questionnaire during the web-screening and pre-observation period.
Key exclusion criteria - (1) History/treatment of mental illness, sleep apnea, hypersomnia, narcolepsy, insomnia, or valvular heart disease.
(2) History/treatment of malignancy, cerebrovascular, heart, liver, kidney, hematologic, or endocrine disease.
(3) Undergoing treatment for gynecological diseases (e.g., menopausal disorders, dysmenorrhea).
(4) History of oophorectomy or hysterectomy.
(5) History/treatment of gastrointestinal disease (e.g., gastrectomy, resection; excluding appendectomy alone).
(6) Subjective sleep disorder symptoms (snoring, daytime sleepiness, choking, gasping, insomnia, or witnessed apnea).
(7) Nocturia disrupting sleep.
(8) Having an infant under 1 year old at home.
(9) Bed-sharing with a toddler.
(10) Living with and caring for a person requiring nursing care.
(11) Sharing bedding with others.
(12) Over 5 years postmenopausal.
(13) Lactating, pregnant, possibly pregnant, or planning pregnancy during the study.
(14) Receiving hormone replacement therapy.
(15) Regular use of oral contraceptives or Kampo medicine.
(16) Regular use of supplements for menopausal relief (e.g., equol).
(17) Regular use of supplements/foods/beverages for fatigue, stress, sleep, joint discomfort, or eye strain.
(18) Daily soy isoflavone intake of 50 mg or more.
(19) Treatment/medication for chronic diseases affecting study results.
(20) Current smoker.
(21) Quit smoking within 3 months before informed consent.
(22) Habitual alcohol drinker.
(23) Extremely irregular sleep or dietary habits.
(24) Expected major changes in environment, diet, or exercise during the study.
(25) Potential allergy to the study food.
(26) Current, recent (within 4 weeks), or planned participation in other clinical trials.
(27) Otherwise judged ineligible by the principal investigator.
Target Size - 66
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 09 Day
Date of IRB - 2026 Year 07 Month 09 Day
Anticipated trial start date - 2026 Year 08 Month 19 Day
Last follow-up date - 2026 Year 12 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071185
Disclaimer: Curated by HT Syndication.
