UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051715 |
|---|---|
| Receipt number | R000059022 |
| Scientific Title | Investigating the effects of monitoring dietary biomarkers and drinking vegetable juice on dietary biomarkers and metabolic syndrome related markers in Mongolian adults |
| Date of disclosure of the study information | 2023/07/26 |
| Last modified on | 2023/07/26 12:13:26 |
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Basic information
Public title
Investigating the effects of monitoring dietary biomarkers and drinking vegetable juice on dietary biomarkers and metabolic syndrome related markers in Mongolian adults
Acronym
Investigating the effects of monitoring dietary biomarkers and drinking vegetable juice on dietary biomarkers and metabolic syndrome related markers in Mongolian adults
Scientific Title
Investigating the effects of monitoring dietary biomarkers and drinking vegetable juice on dietary biomarkers and metabolic syndrome related markers in Mongolian adults
Scientific Title:Acronym
Investigating the effects of monitoring dietary biomarkers and drinking vegetable juice on dietary biomarkers and metabolic syndrome related markers in Mongolian adults
Region
| Asia(except Japan) |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the effects of monitoring dietary biomarkers and drinking vegetable juice on dietary biomarkers and metabolic syndrome related markers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Dietary biomarkers X and Y
-Metabolic syndrome related markers (BMI, waist circumference, systolic-, daiastolic- blood pressure, blood total-. LDL-, HDL- cholesterol, blood hemoglobin A1c)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
No intervention
Interventions/Control_2
Measuring and disclosing dietary biomarkers
Interventions/Control_3
A combination of measuring and disclosing dietary biomarkers and providing vegetable juice
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
living in Ulaanbaatar
BMIis higher than 25 kg/m2 on physical examination within the past year
Key exclusion criteria
-Participants receiving treatment or medication for liver failure, renal failure, heart failure, diabetes, or hepatitis
-Participants taking thyroid hormone replacement medication
-Participants with serious circulatory or gastrointestinal diseases that require surgery
-Pregnant or breast-feeding during the study period.
-Participants who may be allergic to vegetable beverages.
-Participants who are participating in other human studies at the start of this study.
-Other participants deemed inappropriate by the principal investigator or co-investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Suganuma |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
3292762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Hiroyuki_Suganuma@kagome.co.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Ushida |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
3292762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Homepage URL
Yusuke_Ushida@kagome.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Public Health
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Ethics Committee
Address
Nihonbashi-hamacho F-Tower, 3-21-1 Nihonbashi-hamacho, Chuo-ku, Tokyo
Tel
03-5623-8501
Takuji_Hayakawa@kagome.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-R05
Org. issuing International ID_1
Kagome Ethics Committee
Study ID_2
No.283
Org. issuing International ID_2
the Ministry of Health Medical Ethics Review Committee Resolution
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 26 | 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
94
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
| 2020 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 01 | 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 | 07 | Month | 26 | Day |
Last modified on
| 2023 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059022
| Research Plan | |
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| 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 |
