UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060072 |
|---|---|
| Receipt number | R000068563 |
| Scientific Title | Effect of food-containing ingredients on increasing lipid consumption at rest |
| Date of disclosure of the study information | 2026/01/07 |
| Last modified on | 2025/12/02 15:50:58 |
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Basic information
Public title
Effect of food-containing ingredients on increasing lipid consumption at rest
Acronym
Effect of food-containing ingredients on increasing lipid consumption at rest
Scientific Title
Effect of food-containing ingredients on increasing lipid consumption at rest
Scientific Title:Acronym
Effect of food-containing ingredients on increasing lipid consumption at rest
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of continuous intake of food components on increasing resting lipid consumption
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of resting lipid consumption
Key secondary outcomes
Resting lipid expenditure, resting energy expenditure, change in resting energy expenditure, respiratory quotient, body temperature, body composition, waist circumference
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Ingredient-containing food (8 weeks)
Interventions/Control_2
Ingredient-free food (8 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy men and women who are 20 <= years old <65.
(2) Subject who can come to the facility on the designated day.
(3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects whose systolic pressure <90 mmHg.
(2) Subjects in pregnancy or lactation
(3) Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks.
(4) Subjects who are applicable to following items
a) Subjects with disease on heart, liver, kidney or other organs complication.
b) Subjects with a previous history of disease on circulatory organs.
c) Subjects who are contracting diabetes.
d) Subjects with a history of cancer, tuberculosis, or other serious illness
(5) Subjects who have an unsteady lifestyle because of a working shift or a night shift.
(6) Smoker
(7) Subjects who drink a lot.
(8) Subjects whose BMI is less the 18.5 or over 30.0
(9) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
128
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 | Fumiko |
| Middle name | |
| Last name | Oikawa |
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
050-1804-2165
Homepage URL
Fumiko_Oikawa@suntory.co.jp
Sponsor or person
Institute
Suntory beverage & Food 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
IRB of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6-1 Miyahara, Yodogawa-ku, Osaka-city, Osaka, JAPAN
Tel
06-6398-0203
fukudaclinicIRB@gmail.com
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
| 2026 | Year | 01 | Month | 07 | 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 | 15 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 02 | 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 | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068563
