UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051306 |
|---|---|
| Receipt number | R000058522 |
| Scientific Title | Research on the effect of pectin-containing food intake on defecation status and skin quality improvement. |
| Date of disclosure of the study information | 2023/06/30 |
| Last modified on | 2023/11/27 18:06:52 |
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Basic information
Public title
Research on the effect of pectin-containing food intake on defecation status and skin quality improvement.
Acronym
Research on the effect of pectin-containing food intake on defecation status and skin quality improvement.
Scientific Title
Research on the effect of pectin-containing food intake on defecation status and skin quality improvement.
Scientific Title:Acronym
Research on the effect of pectin-containing food intake on defecation status and skin quality improvement.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of improving the defecationstatus,intestinal environment, and skin quality when the test food is ingested continuously for 4 week.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation questionnaire.
Key secondary outcomes
Intestinal bacteria analysis.
Skin quality measurement.
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Ingest the test food (food containing pectin) daily at breakfast for 4weeks.
Interventions/Control_2
Ingest the test food daily at breakfast for 4weeks.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document.
2. Healthy Japanese men and women who are between 20 and 30 years of age at the time of consent.
3. Persons who are aware of constipation tendency.
4. Persons who are concerned about dry skin.
Key exclusion criteria
1. Persons who have chronic illness, receiving medication, have a serious disease history.
2. Persons who have less than 2 bowel movements/week.
3. Persons with apple allergy.
4. Persons who regularly use medicines, foods for specified health uses, health foods (including yogurt, natto, bananas, etc.), etc. that may affect the intestinal environment and skin quality.
5. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam.
6. Persons who are pregnant, planning or hoping to be pregnant during the study period.
7. Persons who are judged as inappropriate for study participants by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Momoko |
| Middle name | |
| Last name | Asano |
Organization
Unitec Foods Co., Ltd.
Division name
Research & Development Division R & D Group
Zip code
1030003
Address
14-4Nihonbashi kodenmacho,Chuoku,Tokyo,Japan
TEL
03-3639-2071
asano.m@unitecfoods.co.jp
Public contact
Name of contact person
| 1st name | Misato |
| Middle name | |
| Last name | Nakamura |
Organization
Unitec Foods Co., Ltd.
Division name
Research & Development Division R & D Group
Zip code
1030003
Address
14-4Nihonbashi kodenmacho,Chuoku,Tokyo,Japan
TEL
03-3639-2071
Homepage URL
mnakamura@unitecfoods.co.jp
Sponsor or person
Institute
Unitec Foods Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Unitec Foods Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Laboratory of Pathophysiological Nutrition, Department of Food and Nutrition, Faculty of Agriculture, Kinki University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioethics Committee, Faculty of Agriculture, Kinki University
Address
3327-204 Nakamachi, Nara City, Nara Prefecture
Tel
0742-43-1628
tatsuki@nara.kindai.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
| 2023 | Year | 06 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | 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
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 09 | Day |
Last modified on
| 2023 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058522
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
