UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054881 |
|---|---|
| Receipt number | R000062706 |
| Scientific Title | Effect of long-term beetroot supplementation on human thermoregulatory response in cold (single group pilot test) |
| Date of disclosure of the study information | 2024/07/07 |
| Last modified on | 2025/01/19 07:49:09 |
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Basic information
Public title
Effect of long-term beetroot supplementation on human thermoregulatory response in cold (pilot test)
Acronym
Long-term beetroot supplementation on thermoregulation in cold (pilot test)
Scientific Title
Effect of long-term beetroot supplementation on human thermoregulatory response in cold (single group pilot test)
Scientific Title:Acronym
Long-term beetroot supplementation on thermoregulation in cold (pilot test)
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
Metabolic response during mild cold exposure test before and after the long-term beetroot juice intake
Key secondary outcomes
Skin blood flow during hand cold immersion test before and after the long-term beetroot juice intake
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume 70 mL of beetroot juice every day during 4-week intervention period.
Interventions/Control_2
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 5 weeks
Those who be able to give written informed consent to participate in this study
Key exclusion criteria
Those who with extremely irregular sleeping or eating habits
Those who run for 3 hours or more per day, 6 days or more per week, or have an equivalent or greater exercise habit
BMI more than 30, or SBP more than 140 mmHg, or DBP more than 90 mmHg
Those who habitually consume food or drink containing beetroot
Those who the principal investigator or co-investigator deems inappropriate to be study participants
Target sample size
10
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
B13, 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
Ministry of Education, Culture, Sports, Science and Technology
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
| 2024 | Year | 07 | Month | 07 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 04 | Day |
Last modified on
| 2025 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062706
