UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048861 |
|---|---|
| Receipt number | R000055627 |
| Scientific Title | Effects of supplements containing multiple ingredients on fasting blood glucose levels, triglyceride levels, and blood pressure in healthy subjects -A randomized, placebo-controlled, double-blind, parallel-group study |
| Date of disclosure of the study information | 2023/09/15 |
| Last modified on | 2024/03/11 09:46:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of supplements containing multiple ingredients on fasting blood glucose levels, triglyceride levels, and blood pressure
Acronym
Effects of supplements containing multiple ingredients on fasting blood glucose levels, triglyceride levels, and blood pressure
Scientific Title
Effects of supplements containing multiple ingredients on fasting blood glucose levels, triglyceride levels, and blood pressure in healthy subjects -A randomized, placebo-controlled, double-blind, parallel-group study
Scientific Title:Acronym
Effects of supplements containing multiple ingredients on fasting blood glucose levels, triglyceride levels, and blood pressure in healthy subjects -A randomized, placebo-controlled, double-blind, parallel-group study
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of continuous ingestion of supplements containing multiple ingredients in healthy subjects
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of between test food and placebo in changes of blood glucose, triglyceride and blood pressure from baseline in subjects within each range from normal high to mild
Key secondary outcomes
Comparison between test food and placebo in changes of blood glucose, triglyceride and blood pressure from each baseline in the entire subjects
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
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food
Interventions/Control_2
Placebo food
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 aged 20-64 years when consented.
2) Subjects whose levels are included between 100-125 mg/dL in fasting blood glucose or 120-199 mg/dL in fasting triglyceride at the time of screening.
3) Subjects who can be available on schedule days.
4) Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria
1) Subjects who have been diagnosed as metabolic syndrome
2)Subjects with a history of hepatic, renal, cardiac or organ disorders, diabetes or other serious diseases.
3) Subjects with a surgical history of digestive system (except appendicectomy).
4) Subjects currently under treatment with chronic diseases.
5) Subjects with food allergies to the food used in the study.
6) Subjects who wish to become pregnant during the study period or who are lactating or pregnant or may be pregnant.
7) Heavy drinkers (average amount of intake as pure alcohol is 60 g or more per day).
8)Subjects who take supplement emphasizing the inclusion of inulin, epigallocatechin, chlorogenic acid, epigallocatechin gallate, indigestible dextrin, 5-aminolevulinic acid, gallic acid, lactoferrin, mulberry leaf extract, salacia extract, kudzu flower extract, African mango tree extract, DHA / EPA, or rose hip extract or general health foods(e.g., protein diet) for 3 days or more per week and have continued to take it for 6 months or more T, and who cannot stop taking it during the study period .
9) Subjects taking the medicines (e.g., the Bislat Gold EX or the Naishitol Zaf), the Chinese medicine (e.g., the Bofutsushosan or the Daisaikoto) or the supplements claiming for the reduction of the body fat on diet.
10) Subjects who are participating in clinical trials or consumer monitoring other than this study or who are planning to participate during this study period.
11) Subjects who have donated 200 ml or more of blood after 1 month before the primary screening or plan to donate them before the end of the study.
12) Subjects who frequently skip breakfast.
13) Subjects who work during 22:00 to 6:00 (shift worker, night- shift worker, etc.).
14) Subject who need to avoid consuming food whose origin is not clearly indicated due to religious or other reasons.
15) Subjects judged as unsuitable for this study by the investigator with other reasons.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Takano |
Organization
Medical Corporation Hokubukai
Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1 Shin-ei, Kiyota-ku, Sapporo, Hokkaido 004-0839 Japan
TEL
011-882-0111
matsuda@ughp-cpc.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Takehara |
Organization
Clinical Support Corporation, Ltd.
Division name
Food Service Division
Zip code
060-0061
Address
4-1 South 1 West 8, Chuo-ku, Sapporo, Hokkaido 060-0061 Japan
TEL
011-223-3130
Homepage URL
takehara@csc-smo.co.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujifilm 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 Ethics Review Board
Address
61-1 Shin-ei, Kiyota-ku, Sapporo, Hokkaido 004-0839 Japan
Tel
011-882-0111
matsuda@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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | 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
| 2022 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 06 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055627
