UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059692 |
|---|---|
| Receipt number | R000068253 |
| Scientific Title | Evaluation of the effect of a test food on lipid metabolism during sleep |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/06 17:54:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the effect of a test food on lipid metabolism during sleep
Acronym
Evaluation of the effect of a test food on lipid metabolism during sleep
Scientific Title
Evaluation of the effect of a test food on lipid metabolism during sleep
Scientific Title:Acronym
Evaluation of the effect of a test food on lipid metabolism during sleep
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the lipid metabolism following a single ingestion of a food ingredient in men aged 20-64 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fat oxidation
Key secondary outcomes
Carbohydrate oxidation, protein oxidation, energy expenditure, respiratory quotient, EEG, OSA sleep questionnaire, core body temperature, blood glucose levels, fatty acids
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
A single intake of test food 1 will be administered. Following a washout period of 2 days or more, a single intake of test food 2 will be administered.
Interventions/Control_2
A single intake of test food 2 will be administered. Following a washout period of 2 days or more, a single intake of test food 1 will be administered.
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Males aged 20 years or older but under 65 years at the time of consent acquisition
(2) Individuals with a BMI of 18.5 kg/m2 or higher but less than 30.0 kg/m2
(3) Individuals able to visit the designated trial site on the scheduled visit date
(4) Individuals who have fully understood the purpose and content of this trial and have provided informed consent
Key exclusion criteria
(1) Individuals with irregular lifestyles, such as those working rotating day-night shifts
(2) Individuals with a Pittsburgh Sleep Quality Index Global Rating score of 6 or higher
(3) Individuals with a Morningness-Eveningness Questionnaire score of lower than 30 or higher than 70
(4) Individuals unable to sleep while wearing an electroencephalograph
(5) Individuals unable to consume prescribed meals at designated times
(6) Individuals unable to perform fingerstick blood sampling
(7) Individuals unable to wear continuous glucose monitoring devices on the upper arm
(8) Individuals unable to remain in confined spaces for extended periods
(9) Individuals consuming more than 60 g of pure alcohol per day on average
(10) Individuals with smoking habits
(11) Individuals with irregular eating habits
(12) Individuals currently undergoing weight loss or planning to do so during the trial period
(13) Individuals regularly consume health foods or supplements that affect lipid metabolism, such as specific health foods, foods with functional claims, etc.
(14) Individuals with systolic blood pressure below 90 mmHg
(15) Individuals with abnormal electrocardiogram findings
(16) Individuals prone to constipation
(17) Individuals weighing less than 40 kg
(18) Individuals with pacemakers or electrical medical implants
(19) Individuals with dysphagia
(20) Individuals scheduled for magnetic resonance imaging during the trial period
(21) Individuals currently participating as subjects in another human trial, or within 4 weeks of completing such a trial
(22) Individuals with a current or past medical history of any of the following conditions:
A) Heart, liver, or kidney disease(including complications from other diseases)
B) Cardiovascular disease
C) Diabetes
D) Gastrointestinal disease
E) Allergy to the test food or prescribed diet
(23) Any other individual deemed unsuitable for this trial by the principal investigator or study physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Maekawa |
Organization
Suntory beverage & Food limited
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1804-0276
Toshihiro_Maekawa@suntory.co.jp
Public contact
Name of contact person
| 1st name | Kazuto |
| Middle name | |
| Last name | Shiga |
Organization
Suntory beverage & Food limited
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1734-7443
Homepage URL
Kazuto_Shiga@suntory.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
筑波大学 体育系
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 10 | 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
| 2025 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 09 | 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
| 2025 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068253
