Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059324) titled 'Clinical study on the effects of the test beverage on heart rate
- a randomized, placebo-controlled, double-blind, 2-period crossover trial -' on Oct. 15.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved 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 study aims to objectively assess the impact of a single intake of the test beverage on heart rate in healthy men and women aged 20 to under 40.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participants will consume 200 mL of the test beverage (at room temperature) over 5 minutes while seated at rest.
Interventions/Control_2 - Participants will consume 200 mL of the placebo beverage (at room temperature) over 5 minutes while seated at rest.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Age: 20 to under 40 years
2. Sex: Japanese men and women
3. BMI less than 30.0 kg/m^2
4. Non-smokers (no smoking in the past year)
5. Provided written informed consent after receiving sufficient explanation and understanding purpose and procedures of the study
Key exclusion criteria - 1. Currently receiving treatment or medicine (including herbal treatment) for any illness (as-needed use permitted)
2. Have a history of or currently have serious disease of the heart, liver, kidneys, or digestive system
3. Hay fever or allergic rhinitis (seasonal or perennial); those without symptoms during the study period may participate
4. Under dietary or exercise therapy supervised by a physician
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 them during the test period
6. Difficulty in proper heart rate measurement or device attachment
7. Prone to skin irritation at electrode sites (chest)
8. Difficulty in proper smartwatch measurement (e.g., thick arm hair)
9. Heavy alcohol consumption (>=40 g/day)
10. Excessive daily caffeine intake (>=400 mg/day)
11. Extremely irregular eating habits or irregular lifestyle due to shift work or night shifts
12. Participation in another clinical study currently or within one month before agreeing to participate in this study, or planning to participate in another clinical study during or within 4 weeks after the test period of this study
13. Major life stress events (e.g., moving, job change, bereavement) within 3 months before consent or expected during the study
14. Unable to abstain from alcohol from the day before the study
15. Allergies to medications or foods
16. Frequent urination
17. Pregnant, breastfeeding, or planning pregnancy during the study
18. 18. Unable to consume caffeine due to constitution
19. Deemed unsuitable for participation by the principal investigator
Target Size - 60
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 09 Month 24 Day
Date of IRB - 2025 Year 09 Month 30 Day
Anticipated trial start date - 2025 Year 10 Month 16 Day
Last follow-up date - 2025 Year 12 Month 26 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067843
Disclaimer: Curated by HT Syndication.
