Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062680) titled 'Evaluation of the safety of intake of a nutraceutical containing highly concentrated S-1-propenyl-L-cysteine (S1PC) extract powder and NMN' on Aug. 25.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Tokyo Midtown Clinic
Midtown Clinic Medical Corporation
Condition:
Condition - Healthy individuals
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the safety of intake of the product containing a high concentration of S1PC (20 mg) plus NMN (product name:IMAI-S1) through medical examinations, hematological tests, and blood biochemical tests conducted before, during, and after intake.
To evaluate efficacy by assessing sleep, overall physical condition, and the condition of skin and hair before, during, and after intake, as well as by analyzing plasma and blood cell components, including the concentrations of nicotinamide adenine dinucleotide synthesis-related components in blood cells and plasma, and related activity, such as eNAMPT levels before and after the intake.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intake of IMAI-S1 (S1PC 20mg and NMN 250mg) for 30 days
Eligibility:
Age-lower limit - 40
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Individuals who have received a full explanation of the purpose and contents of this study, have the capacity to provide consent, have sufficiently understood the explanation, voluntarily wish to participate of their own free will, and have provided written consent to participate.
2. Adult men and women who are aged 40 years or older at the time consent is obtained.
Key exclusion criteria - 1. Individuals who have regularly consumed pharmaceuticals or health related products containing nicotinamide adenine dinucleotide intermediate metabolites such as vitamin complexes or nicotinamide mononucleotide or NMN within the past two weeks.
2. Individuals with or suspected of having severe gastrointestinal, hepatic, renal, cardiovascular, hematological, or endocrine disorders, or malignant neoplasms, or a history thereof.
3. Individuals who are breastfeeding or pregnant, or who plan or wish to become pregnant during the study period.
4. Individuals currently taking anticoagulant medication.
5. Individuals with a history of severe allergy to the raw material of the test ingredient (garlic).
6. Individuals otherwise deemed unsuitable for the study by the principal investigator or study collaborators.
Target Size - 30
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 07 Month 08 Day
Date of IRB - 2026 Year 07 Month 14 Day
Anticipated trial start date - 2026 Year 08 Month 06 Day
Last follow-up date - 2026 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071675
Disclaimer: Curated by HT Syndication.