UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047618 |
|---|---|
| Receipt number | R000054299 |
| Scientific Title | A verification study of the promoting effect of the test food on protein digestion and absorption: a randomized, placebo-controlled, double-blind, crossover comparison trial |
| Date of disclosure of the study information | 2022/04/28 |
| Last modified on | 2023/12/15 13:01:06 |
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Basic information
Public title
A verification study of the promoting effect of the test food on protein digestion and absorption
Acronym
A verification study of the promoting effect of the test food on protein digestion and absorption
Scientific Title
A verification study of the promoting effect of the test food on protein digestion and absorption: a randomized, placebo-controlled, double-blind, crossover comparison trial
Scientific Title:Acronym
A verification study of the promoting effect of the test food on protein digestion and absorption
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the promoting effect of the test food on protein digestion and absorption
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The incremental area under the curve (IAUC) of total amino acid
Key secondary outcomes
1. The maximum blood concentration (Cmax), the time to maximum blood concentration (Tmax), and the measured values and the amount of change from before test-food consumption at each assessment point*1 of total amino acid
2. The IAUC, Cmax, Tmax, and the measured values and the amount of change from before test-food consumption at each assessment point*1 of each following item: plasma amino acids fractionation, Fischer ratio, branched-chain amino acids (BCAA), essential amino acids, and nonessential amino acids
*1It indicates before test-food consumption, at 15, 30, 45, 60, 75, 90, and 120 minutes after test-food consumption
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food:
<Period I> Whey protein with malted rice
<Period II> Whey protein without malted rice
Administration:
Dissolve one packet of the test food in water (100 mL) and drink within five minutes.
*The intervention sequence is Period I to Period II, and each food is single ingestion.
*Washout period is for one week or more.
Interventions/Control_2
Test food:
<Period I> Whey protein without malted rice
<Period II> Whey protein with malted rice
Administration:
Dissolve one packet of the test food in water (100 mL) and drink within five minutes.
*The intervention sequence is Period I to Period II, and each food is single ingestion.
*Washout period is for one week or more.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Japanese
2. Female
3. Subjects aged 50 or more
4. Healthy subjects
5. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who have lactose intolerance
5. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use
6. Subjects currently taking medicines (include herbal medicines) and supplements
7. Subjects who are allergic to medications and/or the test-food-related products (particularly milk)
8. Subjects whose dinner time is irregular
9. Subjects who are pregnant, breast-feeding, and planning to become pregnant
10. Subjects who suffer from COVID-19
11. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
12. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Curves Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 28 | 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
44
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 | 04 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 10 | 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 | 04 | Month | 28 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054299
