UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059002 |
|---|---|
| Receipt number | R000067479 |
| Scientific Title | Assessment of Protein Availability of thick Liquid Feeds Powdered by Spray Drying |
| Date of disclosure of the study information | 2025/09/06 |
| Last modified on | 2025/09/05 11:09:24 |
* 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
Assessment of Protein Availability of thick Liquid Feeds Powdered by Spray Drying
Acronym
Assessment of Protein Availability of thick Liquid Feeds Powdered by Spray Drying
Scientific Title
Assessment of Protein Availability of thick Liquid Feeds Powdered by Spray Drying
Scientific Title:Acronym
Assessment of Protein Availability of thick Liquid Feeds Powdered by Spray Drying
Region
| Japan |
Condition
Condition
sarcopenia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Concentrated liquid diets are used to meet energy and nutrient deficiencies when food intake is reduced. They are also used for tube feeding when oral intake is difficult due to dysphagia. Concentrated liquid diets distributed in Japan are mainly liquid, but powdering them offers several significant advantages. Powders obtained by the spray-drying method undergo a significant change in physical properties due to the evaporation of water as well as the temporary exposure of food components to high temperatures. Whether these changes affect the bioavailability of energy and nutrients is unknown. The purpose of this study is to investigate nitrogen delivery during consumption of conventional liquid or powdered concentrated liquid diets to determine if the bioavailability of nitrogen is altered by the powdering process.
Basic objectives2
Others
Basic objectives -Others
Concentrated liquid diets are used to meet energy and nutrient deficiencies when food intake is reduced. They are also used for tube feeding when oral intake is difficult due to dysphagia. Concentrated liquid diets distributed in Japan are mainly liquid, but powdering them offers several significant advantages. Powders obtained by the spray-drying method undergo a significant change in physical properties due to the evaporation of water as well as the temporary exposure of food components to high temperatures. Whether these changes affect the bioavailability of energy and nutrients is unknown. The purpose of this study is to investigate nitrogen delivery during consumption of conventional liquid or powdered concentrated liquid diets to determine if the bioavailability of nitrogen is altered by the powdering process.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary nitrogen excretion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Liquid agricultural liquid diet 200 kcal three times a day for three days, followed by powdered agricultural liquid diet 200 kcal three times a day for three days
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
People who do not habitually engage in strenuous exercise
People who weigh less than 70 kg
Key exclusion criteria
Persons who experienced fever, inflammation, trauma, etc. during the study period
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Saito |
Organization
Hiroshima International University
Division name
Department of Clinical Nutrition, Faculty of Health and Wellness Sciences
Zip code
737-0112
Address
5-1-1, Hirokoshingai, Kure, Hiroshima 737-0112, Japan
TEL
81-823-73-8254
saito-y@hirokoku-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Saito |
Organization
Hiroshima International University
Division name
Department of Clinical Nutrition, Faculty of Health and Wellness Sciences
Zip code
737-0112
Address
5-1-1, Hirokoshingai, Kure, Hiroshima 737-0112, Japan
TEL
81-823-73-8254
Homepage URL
saito-y@hirokoku-u.ac.jp
Sponsor or person
Institute
Hiroshima International University
Institute
Department
Personal name
Funding Source
Organization
Ohkawara Kakohki Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima International University
Address
5-1-1, Hirokoshingai, Kure, Hiroshima 737-0112, Japan.
Tel
81-823-73-8254
saito-y@hirokoku-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
| 2025 | Year | 09 | Month | 06 | 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
6
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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2034 | 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
| 2025 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067479
