Testing a food supplement for reducing stress on students

Not Applicable

• Conditions: Stress; Mental and Behavioural Disorders

• Registration Number: ISRCTN14084189
• Lead Sponsor: ROELMI HPC Srl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-01-26
• Last Update Posted: 5 February 2024
• Study Completion: 2024-04-15

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 42

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified