UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063194 |
|---|---|
| Receipt number | R000072329 |
| Scientific Title | Is octanoic acid (C8:0), a medium-chain fatty acid, more effective when consumed at breakfast or dinner? (2026 study) |
| Date of disclosure of the study information | 2026/10/09 |
| Last modified on | 2026/10/06 20:05:00 |
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Basic information
Public title
A study comparing the effects of medium-chain fatty acid (octanoic acid, C8:0) intake at breakfast versus dinner (2026 study)
Acronym
MCT breakfast versus dinner study (2026)
Scientific Title
Is octanoic acid (C8:0), a medium-chain fatty acid, more effective when consumed at breakfast or dinner? (2026 study)
Scientific Title:Acronym
Effects of octanoic acid intake timing on physical and cognitive function (2026)
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of one month of octanoic acid (C8:0) supplementation at breakfast versus dinner on body composition, physical performance, concentration, and memory in healthy young adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Between-group comparison of the change in handgrip strength from baseline to the end of the one-month intervention.
Key secondary outcomes
Between-group comparisons of changes in body composition (body weight, BMI, body fat mass, skeletal muscle mass, body fat percentage, fat-free mass, skin moisture, oil content, elasticity, estimated skin age, mid-upper arm circumference, triceps skinfold thickness, and calf circumference), physical performance (back strength, vertical jump height, lower-limb strength, respiratory muscle function, and endurance), and concentration and memory (clerical task processing speed, calculation tasks, and the Miyake memory test), assessed at baseline, the midpoint and end of the intervention, and 15 days after intervention completion. Changes in handgrip strength at the intervention midpoint and 15 days after intervention completion will also be compared between groups. Energy and nutrient intake will be assessed using seven-day dietary surveys before, during, and after the intervention. Step counts will also be assessed.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Breakfast group: In addition to their usual diet, participants consume 18 g (151 kcal) of commercially available octanoic acid (C8:0)-based medium-chain triglyceride (MCT) oil mixed with breakfast once daily for one month.
Interventions/Control_2
Dinner group: In addition to their usual diet, participants consume 18 g (151 kcal) of commercially available octanoic acid (C8:0)-based medium-chain triglyceride (MCT) oil mixed with dinner once daily for one month.
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Third- or fourth-year undergraduate students in the Department of Food and Nutrition, Faculty of Contemporary Life Studies, Tezukayama University, who belong to the principal investigator's seminar and for whom written informed consent has been obtained from both the participant and their parent(s) or equivalent family member(s).
Key exclusion criteria
(1) Individuals with a history of or current type 1 diabetes, serious heart disease, liver disease, kidney disease, blood disorders, or other serious conditions.
(2) Individuals with a BMI of 25.0 kg/m2 or higher.
(3) Individuals with a food allergy to the MCT oil used in this study.
(4) Individuals whose baseline dietary assessment indicates that fat intake is outside the range of 20-30% of total energy intake.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Faculty of Contemporary Life Studies, Department of Food and Nutrition
Zip code
631-8585
Address
Gakuenminami 3-1-3, Nara-shi, Nara, Japan
TEL
0742-41-4742
sa-abe@tezukayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Faculty of Contemporary Life Studies, Department of Food and Nutrition
Zip code
631-8585
Address
Gakuenminami 3-1-3, Nara-shi, Nara, Japan
TEL
0742-41-4742
Homepage URL
sa-abe@tezukayama-u.ac.jp
Sponsor or person
Institute
Tezukayama University
Institute
Department
Personal name
Funding Source
Organization
Tezukayama 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
Tezukayama University
Address
Gakuenminami 3-1-3, Nara-shi, Nara, Japan
Tel
0742414742
sa-abe@tezukayama-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2026-23
Org. issuing International ID_1
Tezukayama University Research 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
| 2026 | Year | 10 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 05 | 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
| 2026 | Year | 10 | Month | 06 | Day |
Last modified on
| 2026 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072329
