UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060023 |
|---|---|
| Receipt number | R000068648 |
| Scientific Title | Effect of long-term beetroot supplementation on human thermoregulatory response in cold (Single-blind, placebo-controlled, randomized, crossover trial) |
| Date of disclosure of the study information | 2025/12/09 |
| Last modified on | 2025/12/09 10:59:57 |
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Basic information
Public title
Effect of long-term beetroot supplementation on human thermoregulatory response in cold (cross over test)
Acronym
Long-term beetroot supplementation on thermoregulation in cold (RCT)
Scientific Title
Effect of long-term beetroot supplementation on human thermoregulatory response in cold (Single-blind, placebo-controlled, randomized, crossover trial)
Scientific Title:Acronym
Long-term beetroot supplementation on thermoregulation in cold (RCT)
Region
| Japan |
Condition
Condition
Healthy male volunteers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison between conditions of changes in supraclavicular-chest skin temperature gradient during mild whole-body cold exposure before and after long-term intake of beetroot versus placebo beverage
Key secondary outcomes
Comparison between conditions of changes in skin blood flow during the hand cold immersion test before and after long-term intake of beetroot versus placebo beverages
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | 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 sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Wakabayashi |
Organization
Hokkaido University
Division name
Faculty of Engineering
Zip code
060-8628
Address
N13, W8 Kita-ku Sapporo
TEL
0117066280
wakabayashi@eng.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Wakabayashi |
Organization
Hokkaido University
Division name
Faculty of Engineering
Zip code
060-8628
Address
N13 W8 Kita-ku Sapporo
TEL
0117066280
Homepage URL
wakabayashi@eng.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
N14, W8 Kita-ku Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068648
