Tokyo, Dec. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060023) titled 'Effect of long-term beetroot supplementation on human thermoregulatory response in cold (cross over test)' on Dec. 9.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Hokkaido University
Condition:
Condition - Healthy male volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect of long-term beetroot juice intake on thermoregulatory responses in a cold environment, and to examine whether it enhances non-shivering thermogenesis during whole-body mild cold exposure and skin blood flow after a hand cold water immersion.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - During the 4-week intervention period, participants consume 70 mL of a beetroot beverage daily, and after a washout period, a second intervention is conducted in which they consume a placebo beverage.
Interventions/Control_2 - During the 4-week intervention period, participants consume 70 mL of a placebo beverage daily, and after a washout period, a second intervention is conducted in which they consume a beetroot beverage.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male
Key inclusion criteria - Age 18-30 years
Healthy volunteers who does no need regular medical visits
Those who has no objection to the taste of the beetroot juice and can participate in this study for about 13 months (Two 4-week intervention periods separated by a 10-month washout period)
Those who be able to give written informed consent to participate in this study
Key exclusion criteria - Individuals with extremely irregular sleep or dietary habits
Individuals who engage in running, or equivalent exercise, for >3 hours per day on >6 days per week
Individuals with a BMI >30, or systolic blood pressure >140 mmHg, or diastolic blood pressure >90 mmHg
Individuals with local perfusion disorders (occlusive vascular disease) caused by organic stenosis or obstruction of arteries or veins
Individuals with lymphedema of the upper arm
Individuals undergoing hemodialysis
Individuals who habitually consume foods or beverages containing red beet
Individuals who cannot agree to consume the study beverage after waking and before gargling or brushing teeth
Individuals who have received, or are scheduled to receive, antibiotics within three months prior to obtaining consent
Other individuals deemed unsuitable as study participants by the principal investigator or co-investigators
Target Size - 12
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 08 Day
Date of IRB - 2025 Year 12 Month 08 Day
Anticipated trial start date - 2025 Year 12 Month 15 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068648
Disclaimer: Curated by HT Syndication.
