Tokyo, Oct. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063355) titled 'Effect of NVIF2026-01 intake on autonomic nervous system activity and task performance' on Oct. 20.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Nagase Viita Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy of NVIF2026-01 on autonomic nervous system activity and task performance
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Placebo drink (a single time intake) -> Washout (not less than 1day) -> Test drink, containing NVIF2026-01 (a single time intake)
Interventions/Control_2 - Test drink, containing NVIF2026-01 (a single time intake) -> Washout (not less than 1 day) -> Placebo drink (a single time intake)
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Individuals who are male or female employees of Nagase Viita Co., Ltd., aged 18 to 65 years, and who have been employed by the company for at least one year.
2) Individuals with a body mass index (BMI) of less than 30 kg/m2.
3) Individuals who do not regularly use medications that may affect the study evaluations and who are willing and able to temporarily discontinue their regular dietary supplement intake during the study period.
4) Individuals who are not pregnant, are not suspected of being pregnant, and are not breastfeeding during the study period.
5) Individuals who do not have a known sensitivity to caffeine.
6) Individuals who do not engage in shift work.
7) Individuals who are able to participate in all scheduled study procedures.
8) Individuals who are willing and able to comply with all study requirements.
Key exclusion criteria - Individuals deemed unsuitable for the study by the Principal Investigator or Investigator.
Target Size - 25
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 24 Day
Date of IRB - 2026 Year 09 Month 24 Day
Anticipated trial start date - 2026 Year 10 Month 20 Day
Last follow-up date - 2027 Year 01 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072514
Disclaimer: Curated by HT Syndication.