UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058486 |
|---|---|
| Receipt number | R000066706 |
| Scientific Title | The effect of olive oil intake on metabolism |
| Date of disclosure of the study information | 2025/07/17 |
| Last modified on | 2025/07/16 09:51:47 |
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Basic information
Public title
Effects of olive oil intake on human metabolism
Acronym
Effects of olive oil on metabolism
Scientific Title
The effect of olive oil intake on metabolism
Scientific Title:Acronym
The effect of olive oil on metabolism
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to verify whether olive oil has an effect on energy consumption as an effective treatment for obesity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After taking in olive oil, the subjects were asked to relax for three hours, and then to walk for one hour on a treadmill at an exercise intensity of about 3 METs (walking speed 65-80m/s), which imposed an exercise load. After the exercise, subjects were allowed to rest for four hours, and metabolic measurements were continued to be taken to measure basal metabolic rate and resting metabolic rate after the exercise load.
Key secondary outcomes
After ingestion of olive oil, subjects are asked to relax for three hours, and then to walk for one hour on a treadmill at an exercise intensity of about 3 METs (walking speed 65-80 m/s), which places an exercise load on the subjects. After the exercise, subjects are asked to rest and then their respiratory quotient is measured for four hours.
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subjects' eating and drinking habits are controlled by the experimenter starting from dinner on the day before the measurement (dinner on the day before the measurement, breakfast and lunch on the day of the measurement are provided by the experimenter to the subjects). During this time, subjects are to drink calorie-free water or tea. Before the test, the subjects undergo a physical fitness test to determine the exercise load to be applied during the experiment. On the day of the test, subjects are to consume 30g of olive oil at lunch.
Interventions/Control_2
The subjects' eating and drinking habits are controlled by the experimenter starting from dinner on the day before the measurement (dinner on the day before the measurement, breakfast and lunch on the day of the measurement are provided by the experimenter to the subjects). During this time, subjects are to drink calorie-free water or tea. Before the test, the subjects undergo a physical fitness test to determine the exercise load to be applied during the experiment. On the day of the test, the subjects consume 30g of control rapeseed oil at lunchtime.
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
| 23 | years-old | > |
Gender
Female
Key inclusion criteria
Be in good health.
Key exclusion criteria
Those who have a disease and are currently undergoing treatment
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ohkubo |
Organization
Sendai Shirayuri Women's College
Division name
Faculty of Human Studies, Department of Health and Nutrition
Zip code
981-3107
Address
6-1 Hondacho, Izumi Ward, Sendai City, Miyagi Prefecture
TEL
022-374-5048
t-ohkubo@sendai-shirayuri.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ohkubo |
Organization
Sendai Shirayuri Women's College
Division name
Faculty of Human Studies, Department of Health and Nutrition
Zip code
981-3107
Address
6-1 Hondacho, Izumi Ward, Sendai City, Miyagi Prefecture
TEL
022-374-5048
Homepage URL
t-ohkubo@sendai-shirayuri.ac.jp
Sponsor or person
Institute
Sendai Shirayuri Women's College
Institute
Department
Personal name
Funding Source
Organization
J-Oil Mills Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sendai Shirayuri Women's College
Address
6-1 Hondacho, Izumi Ward, Sendai City, Miyagi Prefecture
Tel
022-372-3171
shomu@sendai-shirayuri.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
仙台白百合女子大学、仙台大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
Results
Respiratory quotient
Metabolic energy
Autonomic nervous system behavior
Results date posted
| 2025 | Year | 07 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
College Students
Participant flow
Adverse events
None
Outcome measures
Changes in energy metabolism after exercise
Changes in respiratory quotient after exercise
Changes in autonomic nervous system after exercise
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 17 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066706
