UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048985 |
|---|---|
| Receipt number | R000055780 |
| Scientific Title | Basic research on nutritional status, metabolism and physiological functions during exercise (Changes in urinary C-peptide excretion due to carbohydrate or protein intake) |
| Date of disclosure of the study information | 2022/09/22 |
| Last modified on | 2024/09/18 15:00:18 |
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Basic information
Public title
Basic research on nutritional status, metabolism and physiological functions during exercise (Research on protein intake and glucose metabolism)
Acronym
Research on protein intake and glucose metabolism
Scientific Title
Basic research on nutritional status, metabolism and physiological functions during exercise (Changes in urinary C-peptide excretion due to carbohydrate or protein intake)
Scientific Title:Acronym
Changes in urinary C-peptide excretion due to carbohydrate or protein intake
Region
| Japan |
Condition
Condition
Healthy person (Adult)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain basic data for elucidating the mechanism of increased insulin secretion and inhibition of muscle protein breakdown associated with skim milk intake
Basic objectives2
Others
Basic objectives -Others
Using urinary C-peptide excretion as an index, insulin secretion after carbohydrate or protein intake is compared.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Urinary C-peptide excretion
(before (1 hour) and after (4 hours) carbohydrate or protein intake)
Key secondary outcomes
Urinary creatinine excretion, etc.
(before (1 hour) and after (4 hours) carbohydrate or protein intake)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
water intake (Exp. 1)a, (washout period), glucose solution intake (Exp. 2)b, (washout period), lactose solution intake (Exp. 3)c, (washout period), skim milk solution intake (Exp. 4)d
a water 250ml, b contains about 47g of glucose in 250ml of water, c contains about 23.5g of lactose in 250ml of water, d contains about 44g of skim milk in 250ml of water
Interventions/Control_2
Exp. 1, (washout period), Exp. 2, (washout period), Exp. 4, (washout period), Exp. 3
Interventions/Control_3
Exp. 1, (washout period), Exp. 3, (washout period), Exp. 2, (washout period), Exp. 4
Interventions/Control_4
Exp. 1, (washout period), Exp. 3, (washout period), Exp. 4, (washout period), Exp. 2
Interventions/Control_5
Exp. 1, (washout period), Exp. 4, (washout period), Exp. 2, (washout period), Exp. 3
Interventions/Control_6
Exp. 1, (washout period), Exp. 4, (washout period), Exp. 3, (washout period), Exp. 2
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
Male and Female
Key inclusion criteria
Healthy men or women between the ages of 18 to 40
Key exclusion criteria
If abnormal findings are found in the medical examination
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Yamada |
Organization
Kanto Gakuin University
Division name
Department of Nutrition and Dietetics, College of Nutrition
Zip code
236-8503
Address
1-50-1 Mutsuura-higashi, Kanazawa-ku, Yokohama, Japan
TEL
045-786-7221
tyyamada@kanto-gakuin.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo |
| Middle name | |
| Last name | Yamada |
Organization
Kanto Gakuin University
Division name
Department of Nutrition and Dietetics, College of Nutrition
Zip code
236-8503
Address
1-50-1 Mutsuura-higashi, Kanazawa-ku, Yokohama, Japan
TEL
045-786-7221
Homepage URL
tyyamada@kanto-gakuin.ac.jp
Sponsor or person
Institute
Kanto Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Kanto Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanto Gakuin University
Address
1-50-1 Mutsuura-higashi, Kanazawa-ku, Yokohama, Japan
Tel
045-786-2924
kenkyu@kanto-gakuin.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
関東学院大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 22 | 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
| Delay expected |
Results Delay Reason
Because the data is being organized.
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 | 17 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 21 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055780
