UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038389 |
|---|---|
| Receipt number | R000043747 |
| Scientific Title | Survey on polyphenol intake: an open survey |
| Date of disclosure of the study information | 2019/10/25 |
| Last modified on | 2019/10/25 13:53:30 |
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Basic information
Public title
Survey on polyphenol intake: an open survey
Acronym
Survey on polyphenol intake: an open survey
Scientific Title
Survey on polyphenol intake: an open survey
Scientific Title:Acronym
Survey on polyphenol intake: an open survey
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation between dietary polyphenol intake and the concentration of total polyphenol in 24 hour-urine and first morning-urine samples
Basic objectives2
Others
Basic objectives -Others
Validity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between dietary polyphenol intake and the concentration of total polyphenol in 24 hour-urine and first morning-urine samples
Key secondary outcomes
The concentration of antioxidant parameters (eg. total antioxidant capacity, 8-OHdG, 8-isoprostane) in 24 hour-urine and first morning-urine samples
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Males and females aged 30 to 69 years-old
(2) BMI: 18.5 - 25.0
(3) Subjects who can maintain normal lifestyle during the survey period
(4) Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria
(1) Subjects who have serious complication or suffer from urgent need of medical treatment
(2) Subjects who can't stop using medicines, supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) that may affect the investigation during the survey periods
(3) Subjects who have a history of and/or contract drug addiction and/or alcoholism
(4) Subjects who have meals less than twice a day
(5) Subjects who work night shifts or shift workers
(6) Subjects who have abnormality in renal function
(7) Subjects who repeats cystitis frequently
(8) Subjects whose menstruation is predicted during the test periods
(9) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption
(10) Subjects who have a history of and/or contract serious diseases (eg, heart disease, liver disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease)
(11) Subjects who are pregnant, lactation, or planning to become pregnant
(12) Subjects who are planning to participate and/or participate in other clinical studies
(13) Subjects who are judged as unsuitable for the current study by the investigator for other reasons
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Kondo |
Organization
Ochanomizu University
Division name
Endowed Research Depeartment "Food for Health"
Zip code
112-8610
Address
2-1-1 Otsuka, Bunkyo-ku, Tokyo
TEL
03-5978-5810
kondo.kazuo@ocha.ac.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Kondo |
Organization
Ochanomizu University
Division name
Endowed Research Depeartment "Food for Health"
Zip code
112-8610
Address
2-1-1 Otsuka, Bunkyo-ku, Tokyo
TEL
03-5978-5810
Homepage URL
kondo.kazuo@ocha.ac.jp
Sponsor or person
Institute
Ochanomizu University
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
Ethical Committee of Nihonbashi Cardiology Clinic
Address
13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.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
お茶の水女子大学 寄附研究部門「食と健康」
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1)Dietary assessment
1. Dietary record
2. Brief-type self-administered diet history questionnaire (BDHQ)
3. Polyphenol intake and lifestyle questionnaire (mark sheet)
4. Brief-type polyphenol intake questionnaire
(2)Determination of urine sample
1. The concentration of total polyphenol, creatinine, and antioxidant parameters (total antioxidant capacity, 8-OHdG, 8-isoprostane etc.) in 24 hour-urine samples
2. The concentration of total polyphenol, creatinine, and antioxidant parameters (total antioxidant capacity, 8-OHdG, 8-isoprostane etc.) in first morning-urine samples
Management information
Registered date
| 2019 | Year | 10 | Month | 25 | Day |
Last modified on
| 2019 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043747
