UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study to evaluate the effects of fish oil containing DHA on the preservation of renal function
Acronym	A clinical study to evaluate the effects of fish oil containing DHA on the preservation of renal function
Scientific Title	A clinical study to evaluate the effects of fish oil containing DHA on the preservation of renal function
Scientific Title:Acronym	A clinical study to evaluate the effects of fish oil containing DHA on the preservation of renal function
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of fish oil containing DHA on the preservation of renal function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of markers of renal function (eGFR, creatinine)
Key secondary outcomes	Changes of markers of renal function (creatinine clearance), Changes of markers relating to renal impairment (urinary L-FABP, albumin/creatinine, NAG, KIM-1, angiotensinogen), Changes of blood pressure, glucose metabolic markers (HbA1c, blood glucose), lipid markers (LDL-C, TG, HDL-C), body weight and other clinical test values

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of capsules (fish oil containing DHA) for 24 weeks
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	45 years-old <=
Age-upper limit	74 years-old >=
Gender	Male
Key inclusion criteria	1) Males between the ages of 45 and 74 years old 2) Subjects whose results at the screening examination fall into either of the following ･ Systolic blood pressure >= 130 mmHg or diastolic blood pressure >= 85 mmHg ･ Fasting blood glucose >= 110 mg/dL ･ Spot urine albumin/creatinine >= 10 mg/g･Cr
Key exclusion criteria	1) Subjects who take medicines having the effect on the present study (diuretics, antihypertensive agents, SGLT2 inhibitors, warfarin, uricosuric agents, etc.) 2) Subjects who take foods for specified health uses, foods with function claims labeled or supplements (reducing triglycerides, blood pressure, blood glucose and having the effects on dysuria) which can affect the data in a main study 3) Subjects with dysuria who cannot collect their urine 4) Subjects receiving a medical history of serious liver disorder, renal disorder or heart diseases 5) Subjects receiving a medical treatment or having a medical history of hepatitis 6) Subjects who have terrible anemia 7) Subjects who have addiction to alcohol 8) Subjects who need assistance by others and who cannot walk independently 9) Subjects who are bleeding (hemophilia, capillary vulnerability, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage, etc.) 10) Subjects who have the possibility of developing allergic symptoms by the test food 11) Subjects having a medical history of hypersensitivity to the test food 12) Subjects currently participating in other clinical trials or planning to participate in other clinical trials during the examination period 13) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 14) Subjects deemed unsuitable by the investigator
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Shinya Middle name Last name Ashida
Organization	Maruha Nichiro Corporation
Division name	Central Research Institute
Zip code	300-4295
Address	16-2, Wadai, Tsukuba, Ibaraki
TEL	029-864-6708
Email	s-ashida@maruha-nichiro.co.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Sugino
Organization	Soiken Inc.
Division name	R&D Division
Zip code	560-0082
Address	Senri Life Science Center 13F,1-4-2, Shinsenre-higashimachi, Toyonaka, Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	Maruha Nichiro Corporation
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	IRB of Fukuda Clinic
Address	Shin-Osaka Brick Building 2F, 1-6-1, Miyahara, Yodogawa-ku, Osaka, Osaka
Tel	06-6398-0203
Email	fukudaclinicIRB@gmail.com

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	2020 Year 10 Month 20 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	Completed
Date of protocol fixation	2018 Year 10 Month 20 Day
Date of IRB	2018 Year 10 Month 20 Day
Anticipated trial start date	2019 Year 04 Month 06 Day
Last follow-up date	2019 Year 10 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 02 Day
Last modified on	2022 Year 10 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041433