UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052423 |
|---|---|
| Receipt number | R000059836 |
| Scientific Title | A study to evaluate the effect of food ingredient in healthy adult on the blood glucose level: a randomized, double-blind, placebo-controlled, parallel study |
| Date of disclosure of the study information | 2024/12/15 |
| Last modified on | 2024/09/25 19:03:47 |
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Basic information
Public title
A study to evaluate the effect of food ingredient in healthy adult on the blood glucose level
Acronym
A study to evaluate the effect of food ingredient in healthy adult on the blood glucose level
Scientific Title
A study to evaluate the effect of food ingredient in healthy adult on the blood glucose level: a randomized, double-blind, placebo-controlled, parallel study
Scientific Title:Acronym
A study to evaluate the effect of food ingredient in healthy adult on the blood glucose level
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of consumption of the test food on postprandial blood glucose in healthy Japanese subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the blood concentration curve (AUC) and change over time, Cmax, delta-Cmax for glucose
Key secondary outcomes
1.IAUC and Cmax of the blood insulin levels Cmax, delta-Cmax
2.total cholesterol
3.LDL-cholesterol
4.HDL-cholesterol
5.TG(triglycerides)
6.HbA1c(NGSP)
7.glycoalbumin
8.1,5-AG
9.HOMA-beta
10.GLP-1(activated)
11.8-OHdG(urine)
12.BAP
13.Oxidized-LDL
14.AGEs score:AGEssensor RQ-1201J-SET
15.fundus examination
16.VAS(5 questions) about sleepness
17.POMS(Profile of Mood States)2:full form
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume test food for 8 weeks
Interventions/Control_2
Consume placebo food for 8 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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Japanese men and women aged 20 to 65 years old at the time of consent
2. Subjects whose glucose level is between 100 mg per dL and 125 mg per dL as a result of screening test.
3. Subjects who have been fully informed of the purpose and content of the research, have the capacity to consent, have voluntarily volunteered to participate based on a good understanding of the purpose and content of the research, and have agreed to participate in the research in writing.
Key exclusion criteria
1.Subjects with serious renal or hepatic disease, cardiac, respiratory, endocrine, or other metabolic diseases.
2.Subjects with chronic disease and uses pharmaceuticals regularly.
3.Subjects with a history of gastrointestinal surgery (except appendicitis) and gastrointestinal diseases affecting digestion and absorption.
4.As a result of screening test, Subjects with diabetic level (6.5% or higher) of HbA1c (NGSP).
5.Subjects with a BMI of 30 or higher.
6.Subjects with medications that may affect blood glucose levels.
7.Subjects who cannot stop taking supplements or health foods (including foods for specified health uses and foods with functional claims) that may affect blood glucose levels, blood lipids, or body fat during the study period.
8.Subjects with drug or alcohol dependence (a history or present illness).
9.Subjects can't abstain from alcohol for 2 days prior to each examination.
10.Subjects who are determined to be unsuitable by the principal investigator based on blood tests of the screening test.
11.Subjects diagnosed as anemic by screening tests and are not suitable for frequent blood sampling.
12.Subjects with diarrhea within one week prior to the screening test date, or who are normally prone to diarrhea.
13.Subjects donated more than 200 mL of blood or component blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent.
14.Subjects with allergies to ingredients of the studied foods (nuts and fruits).
15.Subjects who are participating, or intend to participate, in research involving the ingestion of other foods or the use of pharmaceuticals, or the application of cosmetics and pharmaceuticals.
16.Pregnant women, women who intend to become pregnant during the study period, women who may become pregnant, and women who are breastfeeding.
17.Other subjects deemed inappropriate as research subjects by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tsuge |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Doctor
Zip code
108-0075
Address
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numazu |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Masanori Numazu
Funding Source
Organization
Ezaki Glico Co., Ltd.
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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
| 2024 | Year | 12 | Month | 15 | 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
| 2023 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 05 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059836
