UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050724 |
|---|---|
| Receipt number | R000057792 |
| Scientific Title | Effects of Chocolate Rich in Oleic Acid and Flavanols on Energy Metabolism |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/03/30 14:00:29 |
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Basic information
Public title
Effects of Chocolate Rich in Oleic Acid and Flavanols on Energy Metabolism
Acronym
Effects of Chocolate Rich in Oleic Acid and Flavanols on Energy Metabolism
Scientific Title
Effects of Chocolate Rich in Oleic Acid and Flavanols on Energy Metabolism
Scientific Title:Acronym
Effects of Chocolate Rich in Oleic Acid and Flavanols on Energy Metabolism
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether consumption of chocolate rich in oleic acid and flavanols activates energy metabolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Energy metabolism (energy expenditure, respiratory quotient, fat oxidation, carbohydrate oxidation)
Key secondary outcomes
Serum free fatty acids, hormone secretion, serum metabolites, urine metabolites, sleep EEG, body temperature, heart rate, autonomic nervous activity and gene expression in leukocytes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume common milk chocolate for 2 weeks.
Interventions/Control_2
Consume chocolate rich in oleic acid and flavanols for 2 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Persons with no health problems
Persons with no sleep problems
Key exclusion criteria
Smokers
Shift workers
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Yajima |
Organization
Josai university
Division name
Faculty of Pharmacy
Zip code
340-0295
Address
1-1 Keyakidai, Sakado, Saitama
TEL
049-271-8015
k-yajima@josai.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Yajima |
Organization
Josai university
Division name
Faculty of Pharmacy
Zip code
350-0295
Address
1-1 Keyakidai, Sakado, Saitama
TEL
049-271-8015
Homepage URL
k-yajima@josai.ac.jp
Sponsor or person
Institute
Josai university
Institute
Department
Personal name
Funding Source
Organization
Josai university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Josai university
Address
1-1 Keyakidai, Sakado, Saitama
Tel
049-271-8015
k-yajima@josai.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
| 2023 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2028 | 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 | 03 | Month | 30 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057792
