UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047018 |
|---|---|
| Receipt number | R000053401 |
| Scientific Title | A Study on the Factors Affecting the Variation of Energy Balance Focusing on the Digestion and Absorption Rate |
| Date of disclosure of the study information | 2022/02/27 |
| Last modified on | 2024/02/02 09:27:05 |
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Basic information
Public title
A Study on the Factors Affecting the Variation of Energy Balance Focusing on the Digestion and Absorption Rate
Acronym
A Study on the Factors Affecting the Variation of Energy Balance Focusing on the Digestion and Absorption Rate
Scientific Title
A Study on the Factors Affecting the Variation of Energy Balance Focusing on the Digestion and Absorption Rate
Scientific Title:Acronym
A Study on the Factors Affecting the Variation of Energy Balance Focusing on the Digestion and Absorption Rate
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify inter-individual differences in digestion and absorption in humans
Basic objectives2
Others
Basic objectives -Others
To clarify the regulatory responses of digestion and absorption rates by different energy balance states
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Energy loss from stool and urine.
The intervention period will consist of three different energy balance conditions for eight days each.
Key secondary outcomes
Energy loss of nutrients (protein, carbohydrate, and fat), body weight, blood glucose variability, gut microbiota, and metabolites
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom | Other |
Interventions/Control_1
Overfeeding condition (150% of energy requirement)
Intervention periods was 8 days (4 days in free living conditions and 4 days in laboratory conditions).
Interventions/Control_2
Control condition (100% of energy requirement)
Intervention periods was 8 days (4 days in free living conditions and 4 days in laboratory conditions).
Interventions/Control_3
Energy restriction condition (75% of energy requirement)
Intervention periods was 8 days (4 days in free living conditions and 4 days in laboratory conditions).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects will be adult males aged 20 years or older who have given informed consent for this study.
Key exclusion criteria
1.Under 20 years old
2.BMI over 30 kg/m2
3.Patients with regular medication (diabetes treatment, alpha-blockers, beta-blockers, and other medications that affect metabolism)
4.Those who have diseases that affect metabolism (diabetes, thyroid disorders)
5.Those with a diagnosis of or history of mental illness
6.Patients with pacemakers or other implantable medical devices
7.Those with serious cardiovascular disease.
8.Those with acute stage cancer.
9.Those who have a history of gastrointestinal surgery (mainly esophagus, stomach, duodenum, small intestine, colon, and liver. However, appendicectomy is acceptable)
10.Those with knee or back problems that interfere with daily life.
11.Those who have extremely irregular eating habits.
12.Those who have exercise habits (average 60 minutes/day or more)
13.Those who are currently participating in, or intend to participate in, a study involving the ingestion of other foods, the taking of drugs, or the application of cosmetics or drugs, etc.
14.Those with drinking and smoking habits and cannot be controlled during the study period
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | - |
| Last name | Yoshimura |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Department of Nutrition and Metabolism
Zip code
162-8636
Address
1-23-1 Toyama, Shinjuku-ku, Tokyo
TEL
0332035835
eyoshi@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | EIICHI |
| Middle name | - |
| Last name | Yoshimura |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Department of Nutrition and Metabolism
Zip code
162-8636
Address
1-23-1 Toyama, Shinjuku-ku, Tokyo
TEL
0332035835
Homepage URL
eyoshi@nibiohn.go.jp
Sponsor or person
Institute
National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
1.Japan Science and Technology Agency
2.Grants-in-Aid for Scientific Research
IRB Contact (For public release)
Organization
Institutional Review Board of National Institutes of Biomedical Innovation, Health and Nutrition
Address
7-6-8 Saito Asagi Ibaraki City Osaka Prefecture
Tel
072-641-9829
irb-office@nibiohn.go.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
| 2022 | Year | 02 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 02 | Month | 27 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053401
