UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036384 |
|---|---|
| Receipt number | R000041433 |
| Scientific Title | A clinical study to evaluate the effects of fish oil containing DHA on the preservation of renal function |
| Date of disclosure of the study information | 2020/10/20 |
| Last modified on | 2022/10/04 10:22:39 |
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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
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
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041433
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| Registered date | File name |
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