UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062535 |
|---|---|
| Receipt number | R000071586 |
| Scientific Title | Effects of Continued Consumption of Commercially Available Emergency Foods on Bowel Habits, Blood Pressure, and Glucose Variability: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/08/11 |
| Last modified on | 2026/08/10 11:14:01 |
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Basic information
Public title
A study comparing bowel habits, blood pressure,and glucose changes after 5-day consumption of emergency foods and health-conscious foods in healthy adults
Acronym
EFCT
Scientific Title
Effects of Continued Consumption of Commercially Available Emergency Foods on Bowel Habits, Blood Pressure, and Glucose Variability: A Randomized Crossover Trial
Scientific Title:Acronym
EFCT
Region
| Japan |
Condition
Condition
Changes in bowel habits, blood pressure, body fluid regulation, and glucose variability associated with continued consumption of emergency foods
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to explore the short-term effects of 5-day consumption of commercially available emergency foods, compared with 5-day consumption of health-conscious retort and shelf-stable foods, on bowel movement frequency, stool form, home blood pressure, body fluid composition, blood and urinary markers related to fluid regulation, and interstitial glucose variability measured by continuous glucose monitoring in healthy adult volunteers aged 20 to 60 years. Adherence to the study diets, satisfaction, and safety will also be assessed to identify practical issues in dietary support during disasters.
Basic objectives2
Others
Basic objectives -Others
Exploratory evaluation of the short-term health effects of consuming commercially available emergency foods compared with health-conscious foods.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The between-condition difference in the change in bowel movement frequency during each 5-day intervention period from the 7-day pre-intervention baseline converted to a 5-day equivalent.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will consume three meals per day of commercially available emergency foods for 5 days, followed by a 4-week washout period, and then three meals per day of health-conscious foods for 5 days.
Interventions/Control_2
Participants will consume three meals per day of health-conscious foods for 5 days, followed by a 4-week washout period, and then three meals per day of commercially available emergency foods for 5 days.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants aged 20 to 60 years at the time of informed consent.
No restriction on sex.
Healthy adults who, at the time of study participation, have no acute or chronic disease that interferes with activities of daily living.
Participants who are able to comply with the 5-day study diet, home blood pressure measurements, recording of bowel movements, food intake, and symptoms in a daily diary, blood and urine tests, body fluid composition measurements, and continuous glucose monitoring using the FreeStyle Libre or an equivalent device.
Participants who have received an explanation of the study objectives, procedures, expected benefits, and potential disadvantages, and who voluntarily provide written informed consent.
Key exclusion criteria
Participants with: (1) conditions that may affect outcomes or safety, including hypertension, heart failure, ischemic heart disease, arrhythmia, cerebrovascular disease, chronic kidney disease, diabetes, liver disease, inflammatory bowel disease, irritable bowel syndrome, or chronic constipation; (2) regular use of antihypertensives, diuretics, laxatives, antidiarrheals, corticosteroids, NSAIDs, or continued use of medications, supplements, dietary fiber products, or foods that may affect blood pressure, body fluid volume, bowel habits, electrolytes, or glucose variability; (3) severe food allergy, prior anaphylaxis, or restriction to allergens in the study foods; (4) pregnancy, possible pregnancy, breastfeeding, or plans for pregnancy during the study; (5) difficulty with blood sampling or substantial sampling-related health risk as judged by an investigator; (6) skin disease, wounds, excessive sweating, severe atopic dermatitis, or severe adhesive/medical-tape dermatitis or allergy preventing upper-arm sensor placement; (7) implanted medical devices such as pacemakers, or planned MRI, CT, X-ray, or other procedures requiring sensor removal during an intervention period and preventing adequate CGM data collection; (8) inability to comply with the study diet or measurements because of dietary restrictions, travel, work schedules, or other circumstances; or (9) any other reason judged by an investigator to make participation inappropriate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Takahashi |
Organization
Tokushima University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
7700042
Address
50-1, 2, kuramotocho, tokushimashi, tokushima, Japan
TEL
0886313111
t.tomonori.0918@gmail.com
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Takahashi |
Organization
Tokushima University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
7700042
Address
50-1, 2, kuramotocho, tokushimashi, tokushima, Japan
TEL
0886313111
Homepage URL
t.tomonori.0918@gmail.com
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Tomonori Takahashi
Funding Source
Organization
Urakami Foundation for Food and Food Culture Promotion
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima university Hospital
Address
50-1, 2, kuramotocho, tokushimashi, tokushima, Japan
Tel
088-633-7958
crb@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
| 2026 | Year | 08 | Month | 11 | 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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 01 | 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 | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071586
