Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062398) titled 'Evaluation of Hydration-Related Physiological Responses Following Consumption of Functional Beverages' on Aug. 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Niigata University
Condition:
Condition - NA
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To elucidate the effects of functional beverage consumption on body fluid balance.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Investigational hydration beverage A
Interventions/Control_2 - Investigational hydration beverage B
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Healthy young adult men and women, approximately 18-30 years of age, who are considered healthy based on self-report and do not have any diagnosed disease or symptoms requiring medical treatment, regular hospital visits, or medical follow-up.
Key exclusion criteria - Participants will be excluded if they:
1. are smokers or have obesity according to Japanese criteria (BMI >25);
2. have a history of cardiovascular disease;
3. have cardiac arrhythmia;
4. have a history of bronchial asthma;
5. have a history of gastrointestinal disease;
6. have epilepsy;
7. are taking medication for chronic disease or other ongoing medical conditions;
8. have previously experienced a vasovagal reaction associated with needle puncture or blood sampling;
9. are unable to undergo capillary blood sampling;
10. regularly consume foods for specified health uses, foods with functional claims, or health foods (including supplements) that may affect the study outcomes at least three times per week and are unable to discontinue them from the time of informed consent (e.g., products containing highly stimulating ingredients such as capsaicin or spices, or those affecting blood flow, body temperature, or sweating);
11. are heavy alcohol drinkers;
12. have allergies to medications or foods relevant to the study;
13. are currently participating in other clinical studies involving pharmaceuticals or health foods, are within 4 weeks of completing such studies, or plan to participate in another clinical study after providing consent for this study;
14. have donated blood components or 200 mL of whole blood within 1 month prior to the start of the study;
15. have donated 400 mL of whole blood within 3 months prior to the start of the study;
16. have a total blood collection volume within the 12 months prior to the study that, when combined with the planned blood collection volume for this study, exceeds 1200 mL; or
17. are considered unsuitable for participation by the principal investigator for any other reason.
Target Size - 25
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 07 Day
Date of IRB - 2026 Year 07 Month 07 Day
Anticipated trial start date - 2026 Year 08 Month 03 Day
Last follow-up date - 2026 Year 12 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071415
Disclaimer: Curated by HT Syndication.
