Tokyo, Sept. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059119) titled 'Verification test of psychological stress reduction effects in middle-aged and elderly women through consumption of test foods' on Sept. 18.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - TES Holdings Co., Ltd.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate the effects of consuming the test food on temporary psychological stress and fatigue experienced in daily life during menopause.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Oral intake of the test food (1 capsule in a day; 8 weeks).
Interventions/Control_2 - Oral intake of the placebo food (1 capsule in a day; 8 weeks).
Eligibility:
Age-lower limit - 40
years-old
Gender - Female
Key inclusion criteria - 1) Women aged 40 to 59 at the time of obtaining consent to participate in the trial.
2) Individuals who are aware of symptoms associated with menopause (irritability, anxiety, mood swings, etc.).
3) Individuals who have received sufficient explanation of the purpose and content of this trial, have the capacity to consent, understand it well, voluntarily volunteer to participate, and can give written consent to participate in this trial.
4) Individuals who can visit the facility on the designated examination date and undergo the examination.
Key exclusion criteria - Individuals
1) who are suffering from any disease and undergoing treatment.
2) with a history of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia, or a history of serious diseases.
3) with a history of severe conditions such as liver, kidney, heart, lung, blood, digestive tract, respiratory, endocrine, metabolic, neurological, or consciousness disorders.
4) with severe anemia.
5) with a Simplified Menopause Index (SMI) of 51 points or higher.
6) with a CES-D Depression Self-Rating Scale score of 16 or higher (suspected depressive state).
7) who have a history of taking or applying medication for the treatment of a disease within the past month.
8) with a BMI of 30.0 kg/m2 or higher.
9) at risk of allergic reactions to components contained in the test food, as well as individuals at risk of allergic reactions to other foods or medications.
10) with a history of continuous consumption of specific health foods, functional foods, health supplements, or dietary supplements within the past three months, as well as individuals planning to consume such products during the trial period.
11) who have undergone placenta therapy within the past three months or currently undergoing such therapy.
12) whose daily alcohol consumption exceeds an average of 20 g/day of pure alcohol per week.
13) with irregular lifestyles, such as shift work or night work.
14) who may change their lifestyle during the trial period.
15) who have had 200 mL of blood drawn within one month prior to the start of the examination, or 400 mL or more within three months prior to the start of the examination.
16) currently participating in other human clinical trials, or individuals who have participated in other human clinical trials within the past three months.
17) who are pregnant, breastfeeding, or have the possibility of becoming pregnant, or who intend to become pregnant during the trial period.
18) Other individuals deemed inappropriate for this trial by the principal investigator.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 01 Day
Date of IRB - 2025 Year 09 Month 02 Day
Anticipated trial start date - 2025 Year 09 Month 27 Day
Last follow-up date - 2025 Year 11 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067509
Disclaimer: Curated by HT Syndication.
