UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048916 |
|---|---|
| Receipt number | R000055717 |
| Scientific Title | Efficacy of animal protein and vegetable protein as space food |
| Date of disclosure of the study information | 2024/12/10 |
| Last modified on | 2025/05/12 14:54:04 |
* 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
Analysis of anti-muscular atrophy effect of cricket protein and soybean protein
Acronym
Novel space food development
Scientific Title
Efficacy of animal protein and vegetable protein as space food
Scientific Title:Acronym
Novel space food development
Region
| Japan |
Condition
Condition
middle aged woman
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of the anti-muscular atrophy effect of cricket protein, soybean protein and cricket protein mixed diet in healthy subjects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this study, in order to investigate the effects of cricket protein and soy protein on physical performance, muscle strength, bone density, and intestinal bacteria, blood, urine, and feces were collected from the subjects before and after taking the test diet for 4 weeks. to measure items such as:
1) Physical measurement, physical function test
Height (measured only once before the start of the test), weight, blood pressure, pulse
Grip strength, knee extension muscle strength, vertical jump, walking speed, etc.
2) Clinical examination
Hematology test: red blood cell count, white blood cell count, hemoglobin level, hematocrit value, platelet count
Blood biochemistry test: sugar metabolism, liver function, renal function, lipid metabolism, pancreatic function
3) 24-hour urine collection test
Urinalysis: Urine general qualitative (urine protein, urinary sugar, urinary urobilinogen)
Urine biochemistry test: urinary Na
Urinary parameters: muscle atrophy markers (3-methylhistidine, creatinine)
Oxidative stress marker (8-deoxyOH)
4) Stool collection
Distribution of intestinal bacteria by next-generation sequencing
5) MRI examination
Quadriceps cross-sectional area, intramuscular fat mass, intramuscular protein mass
6) Bone density measurement
Bone density measurement using a bone densitometer
7) Body composition measurement
Measurement of lean tissue mass and body protein mass with a portable in-body device
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Control meal: Wheat bread
Test period: 28 days
Intake: 1 piece of the above bread daily
Interventions/Control_2
Test meal1: Cricket protein bread (bread containing 8 grams/piece of these proteins)
Test period: 28 days
Intake: 1 piece of the above bread daily
Interventions/Control_3
Test meal2: Soy protein bread (bread containing 8 grams/piece of these proteins)
Test period: 28 days
Intake: 1 piece of the above bread daily
Interventions/Control_4
Test meal3:Cricket and Soy protein-mixed bread (bread containing each 4 grams/piece of these proteins)
Test period: 28 days
Intake: 1 piece of the above bread daily
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy person
Woman
People who have obtained consent from the person
Key exclusion criteria
Those who have a muscle primary disease,
Subjects with moderate or higher renal dysfunction
Those who have diabetes
Subjects who are receiving drugs that affect muscles such as adrenocorticosteroids
Subjects with soybean allergy, crustacean allergy, or wheat allergy
Individuals who take excessive amounts of health supplements containing soybeans
Pregnant or breastfeeding women
People who cannot perform MRI examination due to pacemaker wearing, claustrophobia, etc.
Those who have participated in this study in the past 2 weeks
When the person refuses to participate in this research
When the research director determines that it is difficult to participate in this research
When side effects such as allergies appear and the doctor determines that the use should be discontinued.
When there is an offer from the person to "want to cancel"
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nikawa |
Organization
Tokushima University Graduate School
Division name
Institute of Biomedical Sciences, Department of Nutritional Physiology
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9248
nikawa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nikawa |
Organization
Tokushima University Graduate School
Division name
Institute of Biomedical Sciences, Department of Nutritional Physiology
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9248
Homepage URL
nikawa@tokushima-u.ac.jp
Sponsor or person
Institute
BRAIN (Bio-oriented technology Research Advancement InstitutioN), MoonShot Research & Development Program
Institute
Department
Personal name
Funding Source
Organization
BRAIN (Bio-oriented technology Research Advancement InstitutioN), MoonShot Research & Development Program
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
3-18-15 Kuramoto-cho, Tokushima
Tel
088-633-8512
first-ec@tokushima-u.ac.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
| 2024 | Year | 12 | 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
40
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
| 2022 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 12 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055717
