Tokyo, Sept. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059059) titled 'Study on the effects of test foods on mental health' on Sept. 11.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - Suntory beverage & Food limited.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effect of test food on salivary hormone levels and mood in healthy adult women.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Single administration of test food1.
Interventions/Control_2 - Single administration of test food2.
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - (1) Female subjects ranging in age from 20 to 40 at informed consent.
(2) Subjects who can make self-judgment and voluntarily gave informed consent.
(3) Subjects who can track their menstrual cycle for at least the past three months using app or similar tools.
(4) Subjects whose menstrual cycle is between 25 and 38 days
Key exclusion criteria - (1) Subjects whose systolic blood pressure is less than 90 mmHg
(2) Subjects who are pregnant (including those who may be pregnant) or breastfeeding
(3) Subjects currently participating in other human trials or within four weeks of completing participation in such trials
(4) Subjects who fall under any of the following items:
a) Subjects with diseases of the heart, liver, or kidneys (including those as complications of other diseases)
b) Subjects with a history of cardiovascular disease
c) Subjects who have diabetes
d) Subjects with a history of serious diseases such as cancer and tuberculosis
(5) Subjects who are receiving medical treatment or medication
(6) Subjects having a habit of smoking.
(7) Subjects who consume more than 60 g of pure alcohol per day on average
(8) Subjects having irregular eating habits.
(9) Subjects with irregular life rhythm (e.g., irregular shift work).
(10) Subjects taking medicines or undergoing treatment that affect female hormones, such as pills or hormone replacement therapy
(11) Subjects with a history of mental illness.
(12) Subjects who plan to make significant changes to their lifestyle (eating, sleeping, exercise habits, etc.) during the exam period, such as taking a long trip.
(13) subjects who take healthy foods including soy isoflavones.
(14) Others who were judged as inappropriate for participation by the principal/sub investigator.
Target Size - 32
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 02 Day
Date of IRB - 2025 Year 08 Month 29 Day
Anticipated trial start date - 2025 Year 09 Month 08 Day
Last follow-up date - 2025 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067395
Disclaimer: Curated by HT Syndication.
