UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049119 |
|---|---|
| Receipt number | R000055876 |
| Scientific Title | A study of the effect of continuous intake of test food on body composition, blood markers of glucose/lipid metabolism, blood pressure, and QoL: randomized, placebo-controlled, double blind, parallel-group trial |
| Date of disclosure of the study information | 2022/10/14 |
| Last modified on | 2023/07/05 15:51:47 |
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Basic information
Public title
A study of the effect of continuous intake of test food on body composition, blood markers of glucose/lipid metabolism, blood pressure, and QoL: randomized, placebo-controlled, double blind, parallel-group trial
Acronym
A study of the effect of continuous intake of test food on body composition, blood markers of glucose/lipid metabolism, blood pressure, and QoL
Scientific Title
A study of the effect of continuous intake of test food on body composition, blood markers of glucose/lipid metabolism, blood pressure, and QoL: randomized, placebo-controlled, double blind, parallel-group trial
Scientific Title:Acronym
A study of the effect of continuous intake of test food on body composition, blood markers of glucose/lipid metabolism, blood pressure, and QoL
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial aims to investigate the effect of 12 weeks intake of the test food on body composition, blood markers of glucose/lipid metabolism, blood pressure, and QoL in Japanese males and females aged between 20 and 65 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition
Blood markers test
Blood pressure
QoL questionnaire
Key secondary outcomes
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
Subjects take 2 capsules of test food twice a day (after breakfast and after dinner: 4 capsules a day) with cold or lukewarm water for 12 weeks.
Interventions/Control_2
Subjects take 2 capsules of placebo food twice a day (after breakfast and after dinner: 4 capsules a day) with cold or lukewarm water for 12 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. Those who are aged between 20 and 65 yeas at the time of informed consent.
2. Healthy Japanese males and females.
3. Subjects whose BMI is between 23.0 kg/m2 and 30.0 kg/m2.
4. Those who can record the electronic diary using smartphones or PCs.
5. Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose, and made the written agreement.
Key exclusion criteria
Subjects --
1. who have been currently visiting a hospital or treated with any drug or herbal remedy for any disease.
2. with any of atopic dermatitis, bronchial asthma, chronic bronchitis, acute rhinitis, sinusitis, nasal polyp, hypertrophic rhinitis, deviated nasal septum.
3. who are on diet / exercise therapy under the guidance of a doctor.
4. who currently have or have history of severe diseases.
5. who are on desensitization therapy.
6. daily taking medicine, quasi-medicine, food for specified health uses or nutritional supplements / foods on the market that have health claims related to body fat or slimming. The subjects who can stop taking those medicine or foods during the study are also excluded.
7. daily taking medicine, quasi-medicine, food for specified health uses or nutritional supplements / foods other than criteria 6, except subjects who can stop taking those foods during the study.
8. daily consuming foodstuffs related to the test food with high frequency, except subjects who can refrain from taking these foodstuffs during the study.
9. who currently have or have a history of food and/or drug allergies.
10. who have or have a history of alcoholism or drug addiction.
11. who will take alcohol the day before the visit for tests.
12. routinely taking alcohol more than 60 g/day.
13. with excessive daily smoking: 20 cigarettes a day or more.
14. having plans of major change on their lifestyle (e.g., diet, sleep, and exercise) during the study period.
15. planning to travel abroad during the study period.
16. Currently pregnant, breast-feeding or planning to get pregnant during the study period.
17. who joined or are currently joining other clinical trials within 1 month before receiving informed consent in this study.
18. judged by the physician to be unsuitable for this study.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ozeki |
Organization
Taiyo Kagaku Co., Ltd
Division name
Nutrition Division
Zip code
510-0844
Address
1-3 Tkaramachi, Yokkaichishi, Mie, Japan
TEL
059-347-5411
mozeki@taiyokagaku.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd
Division name
Sales department
Zip code
104-0061
Address
Daiwa Ginza Bldg. 3F, 6-2-1 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6704-5968
Homepage URL
y-hira@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku 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
Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjuku-ku,Tokyo
Tel
03-6704-5968
clinical-trial@imeqrd.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
| 2022 | Year | 10 | Month | 14 | 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
66
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 | 09 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 19 | 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 | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055876
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