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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039742
Receipt No. R000045325
Scientific Title Effects of food ingredients on renal function: a randomized, double-blind, placebo-controlled trial
Date of disclosure of the study information 2020/03/09
Last modified on 2020/03/09

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Basic information
Public title Effects of food ingredients on renal function: a randomized, double-blind, placebo-controlled trial
Acronym Effects of food ingredients on renal function
Scientific Title Effects of food ingredients on renal function: a randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym Effects of food ingredients on renal function
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The randomized, double-blind, placebo-controlled trial is conducted to confirm the effect on renal function by combined supplementation with food ingredients in healthy subjects aged 20-64 years.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Estimated glomerular filtration rate (eGFR)
Key secondary outcomes Creatinine, blood urea nitrogen, amino acids levels

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Food ingredients ingestion once daily at bedtime
Interventions/Control_2 Placebo ingestion once daily at bedtime
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1.20-64 years old
Key exclusion criteria 1. Volunteers with a history of diabetes, liver, renal, and heart diseases, or who taking a medicine daily
2. Volunteers who conducting exercise or diet therapy
3. Volunteers with a history of drug or food allergy
4. Volunteers with hepatitis B antigen
5. Volunteers who are judged not to be appropriate as the subjects in this trial
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yasunori
Middle name
Last name Nakamura
Organization Asahi Quality and Innovations,Ltd.
Division name Core Technology Laboratories Director
Zip code 302-0106
Address 1-21,Midori 1-chome,Moriya-shi,Ibaraki
TEL 0297-46-1671
Email yasunori.nakamura@asahi-qi.co.jp

Public contact
Name of contact person
1st name Shunji
Middle name
Last name Oshima
Organization Asahi Quality and Innovations,Ltd.
Division name Core Technology Laboratories Project Manager
Zip code 302-0106
Address 1-21,Midori 1-chome,Moriya-shi,Ibaraki
TEL 0297-46-9351
Homepage URL
Email shunji.oshima@asahi-qi.co.jp

Sponsor
Institute Asahi Quality and Innovations,Ltd.
Institute
Department

Funding Source
Organization Asahi Quality and Innovations,Ltd.
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 Suda Clinic institutional review board
Address 2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel 03-6205-6222
Email suda-clinic_irb@imeq.co.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

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 09 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
2020 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 06 Day
Last follow-up date
2020 Year 06 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 09 Day
Last modified on
2020 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045325

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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