UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000034129
Receipt No. R000038909
Scientific Title Efficacy trial of continuous ingestion of plant derived ingredients. [trial number g2018006]
Date of disclosure of the study information 2018/09/20
Last modified on 2019/08/21 (Ver. 5)

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Basic information
Public title Efficacy trial of continuous ingestion of plant derived ingredients. [trial number g2018006]
Acronym Efficacy of plant derived ingredients. [trial number g2018006]
Scientific Title Efficacy trial of continuous ingestion of plant derived ingredients. [trial number g2018006]
Scientific Title:Acronym Efficacy of plant derived ingredients. [trial number g2018006]
Region
Japan

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

Objectives
Narrative objectives1 To investigate effects of continuous ingestion of plant derived ingredients for 4 weeks on glucose metabolism in healthy adults with high normaland impaired fasting glucose
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood glucose
Key secondary outcomes Insulin, glucagon, 1.5-AG, glycol-albumin, gastrointestinal hormone, triglyceride, free fatty acids, apo B48, ketone body, body weight, body fat ratio, appetite (questionnaire)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Control food A, once daily,
continuous ingestion for 4 weeks
Interventions/Control_2 Test food B, once daily,
continuous ingestion for 4 weeks
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
64 years-old >=
Gender Male
Key inclusion criteria (1) Healthy male adults aged 20 and older, under 65
(2) Subjects with fasting glucose ranged 100 mg/dL and more, less than126 mg/dL
(3) Subjects can consume test foods, and record life diaries and meal diaries
(4) Subjects who have given written informed consent prior to study
Key exclusion criteria (1)Subjects diagnosed with diabetes, or taking drugs related diabetes
(2)Subjects who have history or symptom of cardiovascular disease or cerebrovascular disease
(3)Subjects who have symptom of liver, kidney or respiratory disease, endocrine disorder, metabolic disorder, organ disorder, gout, rheumatism, autoimmune disease, allergy disease, mental disorder, cancer, infection disease, or other diseases
(4)Subjects who have a history of resection of gastrointestinal tract, excluding cecal resection surgery
(5)Heavy drinker (over 30g alcohol per day)
(6)Subjects who have donated over 200 mL of blood within the last one month prior to the current study or over 400 mL of blood within the last three months prior to the study
(7)Subjects who have severe anemia (Hb <=7g/dL)
(8)Subjects who have food allergies for test foods
(9)Subjects who plan to participate in other clinical study during the current study
(10)Subjects who are judged to be inappropriate for the study by the medical doctor or investigator for other reasons
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Masanobu
Middle name
Last name Hibi
Organization Kao Corporation
Division name Biological Science Research laboratories
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL 03-5630-7266
Email hibi.masanobu@kao.com

Public contact
Name of contact person
1st name Masanobu
Middle name
Last name Hibi
Organization Kao Corporation
Division name Biological Science Research laboratories
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL 03-5630-7266
Homepage URL
Email hibi.masanobu@kao.com

Sponsor
Institute Clinical Support Corporation
Institute
Department

Funding Source
Organization Kao 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 Medical corporation Hokubukai Utsukushigaoka Hospital IRB
Address 61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
Tel 011-882-0111
Email wakimoto@ughp-cpc.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 医療法人社団翔嶺館新札幌聖陵ホスピタル（北海道）

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 20 Day

Related information
URL releasing protocol Unpublished due to the protocol including the intellectual property rights
Publication of results Published

Result
URL related to results and publications works in progress
Number of participants that the trial has enrolled 30
Results 
No significant difference in the primary outcome
Results date posted
2019 Year 08 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Healthy adults with high normal and impaired fasting glucose
Participant flow 
30 participants completed
Adverse events 
No adverse effect related to the test diets reported
Outcome measures 
Glucose
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2018 Year 08 Month 31 Day
Date of IRB
2018 Year 08 Month 30 Day
Anticipated trial start date
2018 Year 09 Month 29 Day
Last follow-up date
2018 Year 12 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 14 Day
Last modified on
2019 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038909