UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053795 |
|---|---|
| Receipt number | R000061383 |
| Scientific Title | Second meal effects of cereal grain based beverages intake |
| Date of disclosure of the study information | 2024/03/14 |
| Last modified on | 2024/03/07 11:28:41 |
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Basic information
Public title
Second meal effects of cereal grain based beverages intake
Acronym
Second meal effects of cereal grain based beverages intake
Scientific Title
Second meal effects of cereal grain based beverages intake
Scientific Title:Acronym
Second meal effects of cereal grain based beverages intake
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we examine second meal effects of cereal grain based beverages, by measuring blood glucose concentrations just before and after consuming beverages with high grain content, low grain content, or grain-free beverages at breakfast (first meal), and just before and after consuming a common test meal at lunch (second meal).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose concentration
Key secondary outcomes
Blood GLP-1 concentration (Blood Glucagon-like peptide-1 concentration), VAS (Hunger, Fullness, Desire-to-eat, Prospective Food Consumption, Thirst, Comfort), Blood Insulin concentration, Breath hydrogen concentrations
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of active food 1
Interventions/Control_2
Single intake of active food 2
Interventions/Control_3
Single intake of Placebo food
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults range in age from 18 to 65 at the time of informed consent
2. Subjects whose defecation frequency are more than 3 times a week
3. Subjects with a BMI of 18.5 or more and less than 25
4. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study
Key exclusion criteria
1. Subjects with food allergies
2. Subjects who suffer from serious disorders of liver, kidney, heart, lung, digestive organs, diabetes, rheumatoid arthritis, neurological/mental diseases, endocrine diseases, or other serious and/or progressive diseases
3. Subjects with a history of stomach, small intestine, or large intestine resection (including appendectomy and colonoscopy)
4. Heavy drinkers (weekly average of 50 g / day or more of pure alcohol)
5. Smoker
6. Subjects who regularly take supplements and health foods for intestinal function or containing prebiotics (e.g. Oligosaccharide, dietary fiber) (Continuing for 2weeks or more at a frequency of 3 or more days a week)
7. Subjects who have a habit of skipping meals (missing meals for 4 or more days a week)
8. Subjects who using blood glucose regulating medications (e.g. hypoglycemic drug, insulin and so on)
9. Subjects who have taken drugs containing antibiotics within the past 4 weeks
10. Subjects who are currently taking oral drug for hay fever and subjects who may be taking it during the study period (However, users who only use nasal sprays and eye drops are not excluded)
11. Subjects who are currently pregnant or breastfeeding, or who wish to become pregnant during the test period.
12. Subjects who donated more than 200ml blood within the past 1 month
13. Subjects who participate in other clinical trials within the past 3 months or have plans to participate in other clinical trials during this study period
14. Subjects who determine ineligible by the principal investigator or the co-investigator
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Kawai |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, Japan
TEL
+81-42-632-5810
yoshitaka.kawai@meiji.com
Public contact
Name of contact person
| 1st name | Atsumi |
| Middle name | |
| Last name | Miyagawa |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, Japan
TEL
+81-42-632-5810
Homepage URL
atsumi.miyagawa@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Otsuma Women's University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiyoda Paramedical Care Clinic
Address
2nd floor, Daiwa Building, 3-3-10 Hongoku-cho, Nihonbashi, Chuo-ku, Tokyo, Japan
Tel
+81-3-6225-9005
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
MIJ24C2
Org. issuing International ID_1
CPCC Company Limited
Study ID_2
2023-022
Org. issuing International ID_2
Meiji Co., Ltd.
IND to MHLW
Institutions
Institutions
チヨダパラメディカルケアクリニック
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 03 | Month | 07 | Day |
Last modified on
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061383
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