Tokyo, Dec. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060222) titled 'Study to Confirm the Effects of Sea Buckthorn Juice Intake on Immune Activity and Physical Condition' on Dec. 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Sajii-berry Holdings inc.
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective is to investigate whether pDC activity in dendritic cells increases and to examine the frequency of cold symptoms during the intake period in 140 adult men and women who subjectively perceive themselves as susceptible to colds, by having them consume Sea Buckthorn juice or placebo juice for 12 weeks.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intake of Sea Buckthorn juice
Interventions/Control_2 - Intake of placebo juice
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Healthy adult men and women aged 20 to 60 years
(2) Individuals who subjectively perceive themselves as prone to catching colds
(3) Individuals who can provide written informed consent to participate in the study
Key exclusion criteria - (1) Individuals currently receiving medication for any disease
(2) Individuals with serious diseases or psychiatric disorders affecting glucose metabolism, lipid metabolism, liver function, kidney function, heart, circulatory system, respiratory system, endocrine system, immune system, or nervous system. Also, individuals with a history of such conditions
(3) Individuals with a disease currently undergoing treatment, or those with a history of serious disease requiring medication
(4) Individuals participating in another clinical study at the start of this trial
(5) Individuals deemed unsuitable for trial participation by the Principal Investigator (or Study Director)
Target Size - 140
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 20 Day
Anticipated trial start date - 2026 Year 01 Month 03 Day
Last follow-up date - 2026 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068884
Disclaimer: Curated by HT Syndication.