Tokyo, March 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061083) titled 'The effects of a test food on attenuating fatigue sensation' on March 27.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - NH Foods Ltd.
Condition:
Condition - Healthy volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effects of the test food on attenuating fatigue sensation
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of test food for 4 weeks
Interventions/Control_2 - Intake of a placebo for 4 weeks
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1)Males and females aged 20 years or more and less than 65 years
2)Persons having fatigue sensation in daily life
3)Persons with a BMI of 18.5 kg/m2 or more, and less than 25.0 kg/m2
4)Persons receiving sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study, and being able to personally sign a written informed consent
Key exclusion criteria - 1)Persons receiving medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine, or metabolic disorders or having a medical history of these disorders
2)Persons having been diagnosed with chronic fatigue syndrome or idiopathic chronic fatigue
3)Persons whose pure alcohol intake per day is 60 g or more
4)Persons who may develop allergic symptoms from consuming the test food
5)Persons whose lifestyles are irregular such as those who work a night shift
6)Persons planning an oversea trip during the study period
7)Persons regularly taking medicines or quasi-drug products that affect fatigue
8)Persons regularly taking "Food with Functional Claims" that affect fatigue sensation
9)Persons who are pregnant or lactating, or intending to become pregnant during the study period
10)Persons who took part in another clinical study within 3 months prior to the start of the present study or who are currently taking part in another clinical study
11)Persons deemed unsuitable by the investigator
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 17 Day
Date of IRB - 2026 Year 01 Month 17 Day
Anticipated trial start date - 2026 Year 05 Month 22 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069861
Disclaimer: Curated by HT Syndication.
