None listed
Conditions
Interventions
Dietary Supplement : The subjects selected based on inclusion/exclusion criteria were randomly assigned to either the experimental group or the control group and consumed Ecklonia cava ethanol extract
Sponsors
Dong-A University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers who are between the ages of 19 and 75 2. Individuals meeting at least one of the following criteria for stress assessment: 1)Determined to have current symptoms of tension and stress based on a psychiatric interview and questionnaire (VAS) with a psychiatrist (VAS response of 50% or higher). 2)Scoring between 50 and 115 on the Stress Response Inventory (SRI). 3)Scoring between 13 and 16 on the Perceived Stress Scale (PSS). 3. Individuals meeting at least one of the following criteria for depression/anxiety assessment: 1)Scoring between 14 and 45 on the Beck Depression Inventory. 2)Scoring between 8 and 45 on the Beck Anxiety Inventory. 3)Scoring between 40 and 60 on the State-Trait Anxiety Inventory.
Exclusion criteria
Exclusion criteria: 1. Individuals with alcohol use disorder or alcohol-induced disorder. 2. Individuals undergoing rehabilitation treatment due to brain disease. 3. Individuals diagnosed with major depressive disorder, generalized anxiety disorder, etc., based on DSM-V criteria. 4. Individuals with major affective disorders, post-traumatic stress disorder, uncontrolled obsessive-compulsive disorder, schizophrenia, dementia, drug addiction, or similar mental illnesses. 5. Individuals who experienced acute stress within 4 weeks prior to Visit 1 (e.g., death of a family member, incarceration, divorce, separation, debt, running away, misconduct, infidelity, business failure, major illness, remarriage, etc.). 6. Individuals with uncontrolled hypertension (blood pressure = 160/100 mmHg). 7. Individuals with uncontrolled diabetes (fasting blood glucose = 160 mg/dL). 8. Individuals with uncontrolled hyperthyroidism or hypothyroidism. 9. Individuals with a creatinine level more than twice the upper normal limit of the study institution. 10. Individuals with AST (GOT) or ALT (GPT) levels more than three times the upper normal limit of the study institution. 11. Individuals with severe gastrointestinal symptoms. 12. Individuals who have taken psychotropic drugs, sleeping pills, appetite suppressants, oral steroids, or adrenal corticosteroids within 1 month prior to the start of the study. 13. Individuals who have consumed functional health foods approved by the Ministry of Food and Drug Safety for stress relief and sleep improvement within 1 month prior to the start of the study. 14. Individuals who have participated in or plan to participate in another human clinical trial within 1 month prior to the start of this human trial. 15. Individuals exhibiting withdrawal symptoms due to cessation of alcohol or smoking within 1 month prior to the start of the study. 16. Individuals who excessively smoke or drink. 17. Individuals who are pregnant, breastfeeding, or planning to become pregnant during the study period. 18. Individuals with allergies to the components of the study food. 19. Individuals deemed unsuitable by the principal investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline stress/tension symptoms at 8 weeks assessed by the Stress Response Inventory | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline stress/tension symptoms at 8 weeks assessed by the Perceived Stress Scale;Change from baseline stress/tension symptoms at 8 weeks assessed by the Beck Anxiety Inventory;Change from baseline stress/tension symptoms at 8 weeks assessed by the Beck Depression Inventory;Change from baseline stress/tension symptoms at 8 weeks assessed by the State-Trait Anxiety Inventory;Change from baseline stress/tension symptoms at 8 weeks assessed by the Visual Analog Scale;Change from baseline stress/tension symptoms at 8 weeks assessed by the blood marker(cortisol, serotonin, DHEAS, ACTH, BDNF);Change from baseline stress/tension symptoms at 8 weeks assessed by the Neurophysiological test(heart rate, blood tension) | — |
Countries
Korea, Republic of
Contacts
Public ContactSungho Han
Dong-A University
Outcome results
None listed