Stress Mental and Behavioural Disorders
Conditions
Interventions
The active food supplement intervention (SelectSIEVE ® Zen) is a dietary supplement based on plant extracts of lemon balm, elderberry and sacred basil, botanicals known to improve mental well-being. T
Sponsors
ROELMI HPC Srl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects 2. Caucasian ethnicity 3. Age more than 18 years old (included) 4. Attending university and will have at least two exams per examination session 5. Not addicted to smoking and drinking 6. Have not been recently involved in any other similar study (at least 2 months of wash-out) 7. Under effective contraception (oral/not oral) therapy 8. Able to comply with the protocol and follow the protocol’s constraints and specific requirements 9. Commitment to use during the entire study period only the products to be tested 10. Commitment to not use products likely to interfere with the product to be tested 11. Commitment to not vary the normal daily routine (i.e. lifestyle, physical activity, etc.) 12. Subject agrees to not use any food supplement until study completion 13. Avoiding consumption of any food supplement or drugs that can interfere with CNS activity for at least 4 weeks prior to the study start 14. Willing to avoid alcohol assumption for the 24 hours prior to the test visits 15. Aware of the study procedures and have signed an informed consent form and a privacy policy 16. Available and willing to follow the procedure of the study protocol 17. Subjects registered with the National Health Service (NHS) 18. Subjects certifying the truthfulness of the personal data disclosed to the investigator
Exclusion criteria
Exclusion criteria: 1. Does not meet the inclusion criteria 2. Pathological psychological conditions related or not related to stress 3. Known hypersensitivity or allergy to one of the active ingredients 4. Any condition that the principal investigator deems inappropriate for participation 5. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential) 6. Subject with known or suspected food intolerance or food allergy 7. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications 8. Pharmacological treatments (antidepressant, anxiolytic, psychotropic drugs, etc) known to interfere with the tested product 9. Severe concurrent diseases 10. Subjects with a history of drug, alcohol and other substance abuse 11. Subjects with active cancers or on chemotherapy 12. Having a diagnosed chronic disease (blood, cardio-vascular, psychiatric, neuro-degenerative, diabetes, cancer, liver, gastric, kidney etc) and/or under medical treatment 13. Clinical history with relevant presence of any disorder or administration of drugs/food supplement that can potentially interfere with the treatment under study 14. Subjects not able to be contacted in case of emergency 15. Subjects taking part or planning to participate to another clinical study during the study in the same or another investigation centre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mood is assessed using the Profile of Mood State (POMS) at T2 (the day before the first examination) and T3 (the day before the second examination), and after the washout period, at T5 (the day before the first examination) and T6 (the day before the second examination). 2. The perception of stress is assessed using the Perceived Stress Scale (PSS) at T2 (the day before the first examination) and T3 (the day before the second examination), and after the washout period, at T5 (the day before the first examination) and T6 (the day before the second examination). 3. Cortisol level is measured by salivary swab at T1 (2 weeks before the first examination), T2 (the day before the first examination) and T3 (the day before the second examination), and then after a washout period (around 60 days), at T4 (2 weeks before the first examination), T5 (the day before the first examination) and T6 (the day before the second examination). 4. Product efficacy and other product properties are assessed using a self-assessment questionnaire 24 hours after the second examination at each exam session (T3 + 24 h and T6 + 24 h) | — |
Secondary
| Measure | Time frame |
|---|---|
| Product safety assessed using adverse events notification throughout the study | — |
Countries
Italy
Contacts
Public ContactIleana De Ponti
Outcome results
None listed