UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055203 |
|---|---|
| Receipt number | R000063079 |
| Scientific Title | Study of measurement on body temperature, exhaled gas, and autonomic nerve of admission for functional foods |
| Date of disclosure of the study information | 2024/08/23 |
| Last modified on | 2025/03/23 16:46:36 |
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Basic information
Public title
Study of measurement on body temperature, exhaled gas, and autonomic nerve of admission for functional foods
Acronym
Study of measurement on body temperature, exhaled gas, and autonomic nerve of admission for functional foods
Scientific Title
Study of measurement on body temperature, exhaled gas, and autonomic nerve of admission for functional foods
Scientific Title:Acronym
Study of measurement on body temperature, exhaled gas, and autonomic nerve of admission for functional foods
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A single-blind crossover study will be conducted to examine the time course of change in core body temperature, exhaled gas, autonomic nerve, and VAS(sleepiness, fatigue, hunger, ctc.) after a single intake of macadamia nuts oil using soybean oil as controls.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Deep body temperature: Continuously measured from 21:00 on the previous day until the end of the test (11:45)
Exhaled gas: Measured for 15 minutes (9:00-9:15) before taking the test foods, and for 35 minutes immediately after taking the test food. (9:25-10:00), 30 minutes (10:15-10:45), 15 minutes (11:00-11:15), and 15 minutes (11:30-11:45) .
Autonomic nervous system: Measured before taking the test foods (9:00-9:05), Measured for 5 minutes immediately after taking the test food. (9:25-9:30), 5 minutes (9:40-9:45), 5 minutes (10:15-10:20), 5 minutes (10:40-10:45), 5 minutes (11:10-11:15), 5 minutes (11:40-11:45).
VAS (sleepiness, fatigue, hunger, etc.): before taking the test food, immediately after taking the test foods, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes.
Key secondary outcomes
Time of falling asleep the day before the test and time of waking up on the day of the test
Whether or not you are menstruating on the day of the test (women only), your physical condition
Height, weight, morningness/eveningness questionnaire, and Pittsburgh Sleep Quality Index
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
2 and half of roll bread
Interventions/Control_2
1 and half of roll bread + macadamia nuts oil
Interventions/Control_3
2 roll breads + macadamia nuts oil
Interventions/Control_4
2 roll breads + soy bean oil
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 and Female
Key inclusion criteria
Those whose living environment will not change significantly during the test period
Those who can visit the designated test location on the designated test date
Those who can wear a core body temperature measuring device and a wristwatch-type wearable device
Those who can wear a mask for measuring exhaled gas and an autonomic nervous system measuring device
Key exclusion criteria
Those with food allergies to wheat, nuts, soybeans, etc.
Those with a history of treatment for malignant tumors, heart failure, or myocardial infarction
Those currently undergoing treatment for or with a history of the following chronic diseases: arrhythmia, liver disorder, kidney disorder, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, high blood pressure, and other chronic diseases
Those who regularly consume foods for specified health uses or foods with functional claims and are unable to stop consuming them while participating in this study
Those who regularly consume foods containing macadamia nuts oils
Those who regularly use medicines (herbal medicines) or supplements and are unable to stop consuming them while participating in this study
Those who are pregnant, breastfeeding, or intend to become pregnant during the study period
Those who have participated in other clinical trials in the month prior to the study period
Others who the study director deems inappropriate for this study
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Motoya |
| Middle name | |
| Last name | Ikeguchi |
Organization
Okayama Prefectural University
Division name
Faculty of Health and Welfare Science, Department of Nutritional Science
Zip code
719-1197
Address
111, Kuboki, Soja-shi, Okayama
TEL
0866942154
motoya_ikeguchi@fhw.oka-pu.ac.jp
Public contact
Name of contact person
| 1st name | Motoya |
| Middle name | |
| Last name | Ikeguchi |
Organization
Okayama Prefectural University
Division name
Faculty of Health and Welfare Science, Department of Nutritional Science
Zip code
719-1197
Address
111, Kuboki, Soja-shi, Okayama
TEL
0866942154
Homepage URL
motoya_ikeguchi@fhw.oka-pu.ac.jp
Sponsor or person
Institute
Okayama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Chusei Oil co.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Graduate School of Biomedical and Health Science, Hiroshima University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Prefectural University Ethics Committee
Address
111, Kuboki, Soja-shi, Okayama
Tel
0866942154
motoya_ikeguchi@fhw.oka-pu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
24-02
Org. issuing International ID_1
Okayama Prefectural University Ethics Committee
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 | 08 | Month | 23 | 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
8
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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 10 | 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 | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063079
