Tokyo, July 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061893) titled 'A Study on the Effects of Continuous Consumption of Test Foods on Mental Health-related Indicators' on July 22.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Other

Condition: Condition - Healthy subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study will examine the effects of continuous consumption of the test food over a 4-week period on mental health-related indicators among Japanese men aged 30 to 59. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of active food - Washout period- Intake of placebo food Interventions/Control_2 - Intake of placebo food - Washout period - Intake of active food

Eligibility: Age-lower limit - 30 years-old

Gender - Male Key inclusion criteria - 1.Japanese men aged 30 to 59 at the time of obtaining written consent 2.Subjects with a T-score of less than 50 on the Friendship (F) scale of the POMS 2 Adult Short Form in the primary screening (SCR). 3.Subjects with a free testosterone level of 11.8 pg/mL or higher in the secondary screening (SCR). 4.Subjects with a total score of less than 10 on the PHQ-9 in the secondary screening (SCR). 5.Subjects who live with family members or a partner. 6.Subjects who are employed and engaged in desk work. 7.Subjects who have not experienced major life events such as bereavement or divorce within the past six months. 8.Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study in writing. Key exclusion criteria - 1.Subjects who have severe mental disorders. 2.Subjects who have a history of testosterone treatment. 3.Subjects who are taking medication or under medical treatment. 4.Subjects who are under exercise therapy or dietetic therapy. 5.Subjects with current or history of drug dependence or alcohol dependence. 6.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past. 7.Subjects with irregular life rhythms due to night shifts or shift work. 8.Subjects with extremely irregular lifestyle habits such as eating and sleeping. 9.Subjects who have an extremely unbalanced diet. 10.Subjects who have a smoking habit (i.e., those who have smoked within the past year). 11.Subjects with heavy alcohol consumption.(Subjects whose average daily net alcohol intake exceeds approximately 60 g) 12.Subjects with serious current or previous illnesses such as brain disease, malignancy, immunological disease, diabetes, liver disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal gland disease, or other metabolic diseases. 13.Subjects who are using dietary supplements, health foods, or medications that may affect mental status. 14.Subjects who are expected to experience major changes or high levels of stress in their home or work environment during the study period (e.g., job change, relocation, marriage). 15. Subjects who have participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period. 16.Subjects who have collected 200 mL of blood or donated more than 400 mL of blood within 3 months from the date of consent acquisition. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 01 Day Date of IRB - 2026 Year 05 Month 21 Day Anticipated trial start date - 2026 Year 07 Month 13 Day Last follow-up date - 2027 Year 03 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070752

Disclaimer: Curated by HT Syndication.