UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051761 |
|---|---|
| Receipt number | R000052680 |
| Scientific Title | Effects of carbohydrate intake on thermogenic hormone and brown fat activity |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2024/11/23 15:20:36 |
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Basic information
Public title
Effects of carbohydrate intake on thermogenic hormone and brown fat activity
Acronym
Effects of carbohydrate intake on thermogenic hormone and brown fat activity
Scientific Title
Effects of carbohydrate intake on thermogenic hormone and brown fat activity
Scientific Title:Acronym
Effects of carbohydrate intake on thermogenic hormone and brown fat activity
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study designed to evaluate the acute and short-term effects of fructose load on brown adipose tissue activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of single and 2-week consumption of fructose on brown adipose tissue activity were evaluated.
Key secondary outcomes
Effects of single and 2-week consumption of fructose on blood fibroblast growth factor 21 levels were evaluated.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A 2-week daily intake of fructose solution, which dissolved 30 g of fructose in 225 mL of a water.
Interventions/Control_2
A 2-week daily intake of 255 mL of a water.
Interventions/Control_3
A single intake of fructose solution, which dissolved 30 g of fructose in 225 mL of a water.
Interventions/Control_4
A single intake of 255 mL of a water.
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
Healthy young men
Key exclusion criteria
The individual who has a history of severe diseases.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Taniguchi |
Organization
Kyoto Prefectural University
Division name
Graduate School of Life and Environmental Sciences
Zip code
606-8522
Address
1-5 Hangi-cho, Shimogamo, Sakyo-ku, Kyoto
TEL
075-703-5415
hirokazu-t@kpu.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Taniguchi |
Organization
Kyoto Prefectural University
Division name
Graduate School of Life and Environmental Sciences
Zip code
606-8522
Address
1-5 Hangi-cho, Shimogamo, Sakyo-ku, Kyoto
TEL
075-703-5415
Homepage URL
hirokazu-t@kpu.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University
Institute
Department
Personal name
Hirokazu Taniguchi
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
Kyoto Prefectural University
Address
1-5 Hangi-cho, Shimogamo, Sakyo-ku, Kyoto
Tel
075-703-5212
kikaku@kpu.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
京都府立大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1186/s40101-023-00353-0
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1186/s40101-023-00353-0
Number of participants that the trial has enrolled
37
Results
In the cross-over single-load trial, plasma FGF21 levels were significantly increased at 2 h after oral fructose load; however, there was no significant difference in BAT activity between the fructose load and drinking water. The 2-week randomized controlled trial revealed that both plasma FGF21 levels and BAT activity were not significantly increased by daily fructose consumption compared to water.
Results date posted
| 2024 | Year | 11 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In this study, 15 healthy young men were participated in a cross-over trial, and 22 healthy young men were participated in a 2-week randomized controlled trial.
Participant flow
In the cross-over trial, 15 young men consumed a single dose of fructose solution or water and then consumed the other on a subsequent day. The randomized controlled trial enrolled 22 young men, and the participants were allocated to a group that consumed fructose and a group that consumed water daily for 2 weeks.
Adverse events
None
Outcome measures
Body surface temperature, anthropometric characteristics, dietary food intake, physical activity, and blood analysis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 07 | Month | 31 | Day |
Last modified on
| 2024 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052680
