UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052068 |
|---|---|
| Receipt number | R000059429 |
| Scientific Title | Investigation of the efficacy of continuous intake of the test food in inhibiting postprandial blood glucose elevation in healthy subjects |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2024/08/01 09:15:21 |
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Basic information
Public title
Investigation of the efficacy of continuous intake of the test food in inhibiting postprandial blood glucose elevation in healthy subjects
Acronym
Investigation of the efficacy of continuous intake of the test food in inhibiting postprandial blood glucose elevation in healthy subjects
Scientific Title
Investigation of the efficacy of continuous intake of the test food in inhibiting postprandial blood glucose elevation in healthy subjects
Scientific Title:Acronym
Investigation of the efficacy of continuous intake of the test food in inhibiting postprandial blood glucose elevation in healthy subjects
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of continuous intake of the test food in inhibiting postprandial blood glucose elevation in healthy subjects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inhibitory effect on postprandial blood glucose elevation
Key secondary outcomes
(Secondary outcomes)
life questionnaire
(Safety evaluation)
Vital signs, physical measurements (body weight and BMI), adverse events
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
Continuous intake of the test food for 2 weeks.
Interventions/Control_2
Continuous intake of the placebo food for 2 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 males and females who are aged 20 years or over and less than 65 at the time of obtaining informed consent.
2.Subjects with HbA1c less than 6.5% in the subject panel data.
3.Subjects with fasting blood glucose less than 126 mg/dL in the subject panel data.
4.Subjects with 120-minute glucose value less than 200 mg/dL as a result of a 75 g oral glucose tolerance test (OGTT) in the subject panel data.
5.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study.
Key exclusion criteria
1.Subjects diagnosed with diabetes mellitus by a physician.
2.Subjects receiving medication or outpatient treatment for a serious disease.
3.Subjects receiving exercise or diet therapy under the supervision of a physician.
4.Subjects who are at risk of developing allergies to the test food or the load food.
5.Subjects with current or previous history of drug dependence or alcohol dependence.
6.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder.
7.Night or shift workers with irregular life patterns.
8.Subjects whose eating, sleeping, and other habits are extremely irregular.
9.Subjects who are having a very unbalanced diet.
10.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more) or excessive smokers (21 cigarettes/day or more).
11.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases.
12.Subjects who routinely use or cannot refrain from using health food, supplements, and medications that affect blood glucose levels.
13.Subjects who routinely use or cannot refrain from using health food, supplements, and medications claiming to contain dietary fiber.
14.Subjects with alcohol hypersensitivity which makes alcohol disinfection difficult.
15.Subjects who have difficulty in blood sampling from a finger tip.
16.Subjects who participated in another clinical study within 2 months before the beginning of test food intakes or who plan to participate in another clinical study during the study period.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
toya@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku Tokyo, 108-0014 Japan
TEL
03-3431-1260
Homepage URL
toya@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Fuji Nihon Seito 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
Miyake Clinic Institutional Review Board
Address
4-2-17 Komagome, Toshima-ku, Tokyo 170-0003 Japan
Tel
03-6903-7211
jim@medipharma.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
| 2023 | Year | 08 | Month | 31 | 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
80
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 | 08 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 17 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 06 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 31 | Day |
Other
Other related information
(Exclusion criteria continued)
17.Subjects who donated more than 200 mL of whole blood, plasma, or platelets within 1 month before the date of informed consent or 400 mL within 3 months before the date of informed consent.
18.Women who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period.
19.Subjects who have difficulty complying with recording of each survey form.
20.Subjects who are judged as inappropriate candidates according to clinical laboratory values in the subject panel data and baseline characteristics at the screening.
21.Other Subjects who are considered ineligible for participation in the study by the investigator.
Management information
Registered date
| 2023 | Year | 08 | Month | 31 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059429
