Clinical trial aimed to evaluate the efficacy of a food supplement in managing stress in university students: a double-blind, placebo-controlled, cross-over study

ROELMI HPC Srl0 个研究点目标入组 42 人开始时间: 2024年1月26日最近更新: 2024年2月5日

适应症

试验速览

暂无简介。

•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

•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

发起方

ROELMI HPC Srl