ISRCTN14084189
Active, Not Recruiting
N/A
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 sites42 target enrollmentJanuary 26, 2024
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stress
- Sponsor
- ROELMI HPC Srl
- Enrollment
- 42
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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