UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062569 |
|---|---|
| Receipt number | R000071564 |
| Scientific Title | Effects of Continuous Soy Protein Intake on Body Composition: A Randomized, Double-Blind, Placebo-Controlled Trial |
| Date of disclosure of the study information | 2026/08/13 |
| Last modified on | 2026/08/13 15:55:59 |
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Basic information
Public title
Effects of Continuous Soy Protein Intake on Body Composition
Acronym
Effects of Continuous Soy Protein Intake on Body Composition
Scientific Title
Effects of Continuous Soy Protein Intake on Body Composition: A Randomized, Double-Blind, Placebo-Controlled Trial
Scientific Title:Acronym
Effects of Continuous Soy Protein Intake on Body Composition: A Randomized, Double-Blind, Placebo-Controlled Trial
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of 12-week continuous intake of a soy protein on waist circumference and body composition in healthy adults with a BMI of 25.0 to <30.0 kg/m2.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
waist circumference and body composition
Key secondary outcomes
1)Bowel movement diary
2)Hunger assessed by VAS
3)Total energy intake (3-day dietary record)
4)Fecal water content and short-chain fatty acid concentrations (acetate, propionate, butyrate, etc.)
5) Changes in gut microbiota composition assessed by 16S rRNA amplicon sequencing
6)Plasma GLP-1 and GIP
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Powdered beverage containing the control food
Interventions/Control_2
Powdered beverage containing test food 1
Interventions/Control_3
Powdered beverage containing test food 2
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Men and women aged 20 to 49 years at the time of obtaining informed consent
2)Individuals with a BMI of 25.0 to <30.0 kg/m2
3)Individuals able to visit the study site on the scheduled visit dates
4)Individuals who have fully understood the purpose and content of the study and have provided written informed consent before the start of the study
Key exclusion criteria
1)History of serious hepatic, renal, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease.
2)Past or current drug or alcohol dependence.
3)Gastrointestinal disease or surgical history affecting digestion, absorption, or defecation.
4)Chronic disease requiring regular medication.
5)Regular use of medications/foods that may affect the study and cannot be restricted from consent onward. 6)Intake >=3 times/week of medications affecting the intestinal environment (laxatives, intestinal regulators, etc.) or foods (yogurt, lactic acid bacteria beverages, fermented foods, oligosaccharides, sugar alcohols, high-fiber foods/supplements).
7)Food allergy to the study food (soy).
8)Pregnant, lactating, or possibly pregnant during the study.
9)Excessive exercise, alcohol (>20 g pure alcohol/day, >=3 times/week), or smoking (>=21 cigarettes/day). 10)Suspected infection on virological/immunoserological tests at screening.
11)Body weight change of >=+/-5 kg within 3 months before screening. 12)Special dietary management for weight loss, or major increase in exercise, within 3 months before screening.
13)Extremely irregular lifestyle or diet (including night-shift workers).
14)Lifestyle expected to change substantially during the study.
15)Antibiotic use within 1 month before consent, or planned during the study.
16)Participation in another clinical trial within 1 month before consent, currently, or planned during the study.
17)Overseas travel planned during the study.
18)Judged unsuitable based on background survey responses.
19)Otherwise judged unsuitable by the principal or sub-investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Hirano |
Organization
Fuji Oil Co., Ltd.
Division name
Research Institute for Creating the Future
Zip code
300-2497
Address
4-3 Kinunodai, Tsukubamirai, Ibaraki, Japan.
TEL
0297-52-6325
hirano.keita@so.fujioil.co.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Hirano |
Organization
Fuji Oil Co., Ltd.
Division name
Research Institute for Creating the Future
Zip code
300-2497
Address
4-3 Kinunodai, Tsukubamirai, Ibaraki, Japan.
TEL
0297-52-6325
Homepage URL
hirano.keita@so.fujioil.co.jp
Sponsor or person
Institute
Fuji Oil Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Fuji Oil Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
APO PLUS STATION CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fuji Oil IRB
Address
4-3 Kinunodai, Tsukubamirai, Ibaraki, Japan.
Tel
0297-52-6325
fujioil.irb@so.fujioil.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 13 | 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 | 08 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 25 | 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 | 08 | Month | 13 | Day |
Last modified on
| 2026 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071564
