Tokyo, March 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057083) titled 'Clinical trial on psychological effect by intake of test beverage - A placebo-controlled, single-blind, crossover study -' on March 11.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - IMEQRD Co. Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to evaluate psychological effects by single intake of test beverage in healthy Japanese males and females 20 years old or older, and under 35 years old.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intake placebo beverage on the day
Interventions/Control_2 - Intake test beverage B on the day
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1.Age: 20 or elder, and less than 35 years
2.Japanese males and females
3.BMI less than 30.0 kg/m^2
4.non-smokers (no history of smoking in the past year)
5. Individuals who have received adequate explanation regarding the trial, can comprehend its contents, and have produced written consent
Key exclusion criteria - 1.Currently undergoing medical, pharmacological, or herbal treatment (except for on-demand medicines)
2.Have a history of, or currently have serious cardiac, hepatic, renal, gastrointestinal disease
3.Have a pollen allergy or (seasonal / perennial) allergic rhinitis appeared to cause the symptoms occurrence in the test period
4.Currently receiving diet therapy or physiotherapy under medical supervision
5.Regularly taking commercially available pharmaceuticals, quasi drugs, foods for specified health use (FOSHU), foods with function claims or health food that affect autonomic nervous system, metabolism or sleep, and unable to stop taking during the test period
6. Have any difficulty in measurement using heart rate monitor (e.g. thick body hair on the chest hair, with an implanted pacemaker, etc.)
7. Have sensitive skin around electrode attachment site (chest)
8. Habitual heavy drinkers (daily pure alcohol consumption exceeding 40g)
9. Have significant inconsistency in timing of meals from day to day, or have an irregular sleep cycle (e.g. shift-workers / night shift worker)
10. Participants in other clinical trials currently or within one month before agreeing to participate in this study, or planning to participate in other clinical trials during or within 4 weeks after the test period of this study
11. May have significant stress due to life events such as relocation, job change or separation from close relatives with in 3 months before consent for this study, or planned to have such life events during this study
12. Have difficulty in abstaining from alcohol from the day before the date when study is conducted
13. Have food or drug allergy
14. frequent urination
15. Currently pregnant or breastfeeding, or hoping to get pregnant during the test period
16. Deemed unsuitable for this study by the principal investigator
Target Size - 60
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 01 Month 23 Day
Date of IRB - 2025 Year 01 Month 28 Day
Anticipated trial start date - 2025 Year 03 Month 12 Day
Last follow-up date - 2025 Year 04 Month 21 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065184
Disclaimer: Curated by HT Syndication.
