UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052637 |
|---|---|
| Receipt number | R000060061 |
| Scientific Title | Evaluation of effects induced by ingesting test foods on lower limb.(SBF-2023-04) |
| Date of disclosure of the study information | 2023/10/31 |
| Last modified on | 2024/12/14 14:50:15 |
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Basic information
Public title
Evaluation of effects induced by ingesting test foods on lower limb.
Acronym
Evaluation of effects induced by ingesting test foods on lower limb.
Scientific Title
Evaluation of effects induced by ingesting test foods on lower limb.(SBF-2023-04)
Scientific Title:Acronym
Evaluation of effects induced by ingesting test foods on lower limb.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify some kind of effect of continuous intake of the food ingredient on calf circumference for male and female subjects ranging in age from 20 to 50 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Calf circumference
Key secondary outcomes
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food 1 (continuous ingestion) -Washout period(4weeks)-Test food 2 (continuous ingestion)
Interventions/Control_2
Test food 2 (continuous ingestion) -Washout period(4weeks)-Test food 1(continuous ingestion)
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Male and Female subjects ranging in age from 20 to 50 at informed consent.
(2)Subjects who feel swelling in their face and legs.
(3)Subjects who can visit the designated facility on measurement days.
(4)Subjects who can make self-judgment and voluntarily gave written informed consent.
Key exclusion criteria
(1)Subjects with a maximal blood pressure of less than 90 mmHg, or subjects with a maximal blood pressure of more than 130 mmHg.
(2)Subjects in pregnancy or lactation
(3)Subjects who donated their blood components and/or whole blood (0.2 L) within the past 4 weeks.
(4)Males who donated their whole blood (0.4 L) within the past 12 weeks.
(5)Females who donated their whole blood (0.4 L) within the past 16 weeks.
(6)Males being collected in total of their blood (1.2 L) within the past 12 months and in this research.
(7)Females being collected in total of their blood (0.8 L) within the past 12 months and in this research.
(8)Subjects being under other clinical tests, or partook in those within the past four weeks, or will join those after the consent.
(9)Subjects who meet any of the following:
(a)suffering from heart, liver, or kidney disease (including complications of other diseases)
(b)having a history of cardiovascular disease
(c)diabetes
(d)allergic to the test food and required one.
(e)having a history of cancer or lymphedema
(10)Subjects with dysphagia
(11)Subjects who have a disease for which they are undergoing treatment and are taking pharmaceuticals (excluding applied drugs, OTC drugs, and quasi-drugs), or who are likely to take pharmaceuticals (excluding applied drugs, OTC drugs, and quasi-drugs) during the study period.
(12)Subjects at risk ofc or other seasonal allergic symptoms during the study period.
(13)Subjects who have periodically used OTC drugs, quasi-drugs and health-specific / functional / health foods including supplements, which might affect this study.
(14)Females whose menstrual cycle is not stable.
(15)Heavy alcohol drinkers or excessive smokers.
(16)Subject who are scheduled to work day and night shifts and night shifts during this examination period.
(17)Subjects who have difficulty maintaining daily routines
(18)Others who were judged as inappropriate for participation by the principal investigator.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Maekawa |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-3182-0663
Toshihiro_Maekawa@suntory.co.jp
Public contact
Name of contact person
| 1st name | Shigeo |
| Middle name | |
| Last name | Moriguchi |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-3182-4525
Homepage URL
Shigeo_Moriguchi@suntory.co.jp
Sponsor or person
Institute
Suntory beverage & Food limited.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Association Watanabe hospital IRB
Address
1-5-16 Haneda, Ota-ku, Tokyo, JAPAN
Tel
03-3741-0223
food-contact@apoplus.co.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
| 2023 | Year | 10 | Month | 31 | 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
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 27 | Day |
Last modified on
| 2024 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060061
