Effects of consumption of the test food on stress in healthy Japanese

Effects of consumption of the test food on stress in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on stress in healthy Japanese

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000052605

Enrollment

100

Registered

2023-10-25

Start date

2023-10-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese

Interventions

Duration: Eight weeks Test food: Capsule containing Lactococcus lactis subsp. cremoris YRC3780 powder Administration: Take one capsule with water without chewing per day. *If you forget to take t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose TMD score in the POMS2 increase after psychological stress load at Scr among those who have agreed to participate 6. Individuals whose TMD score in the POMS2 is relatively high after psychological stress load at Scr among those who met the inclusion criteria No. 1~5 without meeting any of exclusion criteria

Exclusion criteria

Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and/or the test food related products 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 9. Individuals who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 10. Individuals whose sleeping time or habit is irregular due to work such as a late-night shift 11. Individuals who have irregular lifestyles (such as diet, exercise, and sleep) 12. Individuals who are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome 13. Individuals who work in physical labor such as transportation of heavy objects 14. Individuals who drink to excess (average of more than about 20 g/day as pure alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 15. Individuals who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

Measure	Time frame
1. The measured value of Total Mood Disturbance (TMD) in the Profile of Mood States 2nd Edition (POMS2) after psychological stress load at the in-clinic examination after eight weeks of consumption (8w)	—

Secondary

Measure	Time frame
1. The amount of change and rate of change from screening (at the in-clinic examination before consumption; Scr) of TMD in the POMS2 after psychological stress load at 8w 2. The measured value of difference of TMD in the POMS2 between before and after psychological stress load (after load minus before load) at 8w, and its amount and rate of change from Scr 3. The measured value of TMD in the POMS2 before psychological stress load at 8w, and its amount and rate of change from Scr 4. The measured values of Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), Friendliness (F) in the POMS2, subjective fatigue measured by visual analogue scale (VAS), and salivary cortisol after psychological stress load and the difference from before load at 8w, and the amount and rate of changes of them from Scr 5. The measured values of TA, DD, AH, VA, FI, CB, F in the POMS2, subjective fatigue measured by VAS, and salivary cortisol before psychological stress load at 8w, and the amount and rate of changes of them from Scr 6. The measured values of Depression score, Anxiety score, and Stress score in the Depression Anxiety Stress Scales-21 (DASS-21), total score, somatic symptoms (A scale), anxiety and insomnia (B scale), social dysfunction (C scale), and severe depression (D scale) in the General Health Questionnaire-28 (GHQ-28), and total score of the Beck Depression Inventory-Second Edition (BDI-II) at 8w, and the amount and rate of changes of them from Scr 7. The measured values of TMD, TA, DD, AH, VA, FI, CB, and F in the POMS2, subjective fatigue measured by VAS, Depression score, Anxiety score, and Stress score in the DASS-21, total score, A scale, B scale, C scale, and D scale in the GHQ-28, and total score of the BDI-II at the home-based examination after four weeks of consumption, and the amount and rate of changes of them from Scr	—

Measure

Time frame

1. The amount of change and rate of change from screening (at the in-clinic examination before consumption; Scr) of TMD in the POMS2 after psychological stress load at 8w 2. The measured value of difference of TMD in the POMS2 between before and after psychological stress load (after load minus before load) at 8w, and its amount and rate of change from Scr 3. The measured value of TMD in the POMS2 before psychological stress load at 8w, and its amount and rate of change from Scr 4. The measured values of Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), Friendliness (F) in the POMS2, subjective fatigue measured by visual analogue scale (VAS), and salivary cortisol after psychological stress load and the difference from before load at 8w, and the amount and rate of changes of them from Scr 5. The measured values of TA, DD, AH, VA, FI, CB, F in the POMS2, subjective fatigue measured by VAS, and salivary cortisol before psychological stress load at 8w, and the amount and rate of changes of them from Scr 6. The measured values of Depression score, Anxiety score, and Stress score in the Depression Anxiety Stress Scales-21 (DASS-21), total score, somatic symptoms (A scale), anxiety and insomnia (B scale), social dysfunction (C scale), and severe depression (D scale) in the General Health Questionnaire-28 (GHQ-28), and total score of the Beck Depression Inventory-Second Edition (BDI-II) at 8w, and the amount and rate of changes of them from Scr 7. The measured values of TMD, TA, DD, AH, VA, FI, CB, and F in the POMS2, subjective fatigue measured by VAS, Depression score, Anxiety score, and Stress score in the DASS-21, total score, A scale, B scale, C scale, and D scale in the GHQ-28, and total score of the BDI-II at the home-based examination after four weeks of consumption, and the amount and rate of changes of them from Scr

—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026