UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056012 |
|---|---|
| Receipt number | R000064017 |
| Scientific Title | Effect of vegetable and fermented milk intake on carotenoid accumulation and intestinal environment |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/10/31 12:47:39 |
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Basic information
Public title
Effect of vegetable and fermented milk intake on carotenoid accumulation and intestinal environment
Acronym
Effect of vegetable and fermented milk intake on carotenoid accumulation and intestinal environment
Scientific Title
Effect of vegetable and fermented milk intake on carotenoid accumulation and intestinal environment
Scientific Title:Acronym
Effect of vegetable and fermented milk intake on carotenoid accumulation and intestinal environment
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of vegetable and fermented milk intake on carotenoid accumulation and intestinal environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin carotenoid score
Serum carotenoids concentration
Number of bowel movements
Intestinal microbiota
Key secondary outcomes
Serum markers of intestinal barrier function
Stool Condition
Cholesterol uptake capacity
Blood pressure and arterial stiffness indices
Visual Analog Scale scores for skin and bowel conditions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants intake vegetable beverage daily for four weeks.
Interventions/Control_2
Participants intake vegetable beverage with fermented milk daily for four weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy male and female between 18 and 35 years old
2)Voluntarily agrees to participate after understanding the purpose and content of the research, and provides written consent
3)Skin carotenoid score less than 355
Key exclusion criteria
1) Those who are taking, or plan to take during the study period, pharmaceuticals, quasi-drugs, supplements, health foods (food with nutrient function claims, food for specified health uses, food with functional claims), or carotenoid-enriched foods that may affect this study.
2) Those with serious or progressive chronic diseases or symptoms.
3) Those who have been diagnosed with abnormalities in lipid, glucose metabolism, liver function, or renal function.
4) Those who have undergone digestive system surgery in the past.
5) Those with food allergies
6) Those who have difficulty with the taste of the test beverage.
7) Those who expect to be unable to drink the test beverage on days during the test period.
8) Those who are aware that dairy products make them sick to their stomachs.
9) Smokers
10) Those who have difficulty in taking measurements with their fingertips.
11) Those who have difficulty in answering the questionnaire.
12) Pregnant or lactating mothers
13) Other subjects deemed inappropriate as research participants by the principal investigator.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Yoshimi |
| Middle name | |
| Last name | Kishimoto |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
573-0101
Address
45-1, Nagaotoge-cho, Hirakata, Osaka
TEL
0728966352
yoshimi.kishimoto@setsunan.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Kishimoto |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
573-0101
Address
45-1, Nagaotoge-cho, Hirakata, Osaka
TEL
0728966352
Homepage URL
yoshimi.kishimoto@setsunan.ac.jp
Sponsor or person
Institute
Setsunan University
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Setsunan University Ethical Review Committee for Medical and Health Research Involving Human Subjects
Address
17-8, Ikedanaka-machi, Neyagawa, Osaka
Tel
0728001160
setsunan.kenkyu.shakai@josho.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
| 2024 | Year | 11 | Month | 01 | 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
| 2024 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 11 | Month | 01 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064017
