UMIN-CTR Clinical Trial

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
Email	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
Email	kondo.kazuo@ocha.ac.jp

Sponsor
Institute	Ochanomizu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043747