UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047059 |
|---|---|
| Receipt number | R000053673 |
| Scientific Title | Randomized controlled trials of the effects of food supplementation with resistant starch on intestinal microbiota and postprandial blood glucose levels |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/01/16 09:51:28 |
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Basic information
Public title
Study on the effects of resistant starch intake on intestinal regulation and postprandial blood glucose levels
Acronym
Study on the effects of resistant starch intake on intestinal regulation and postprandial blood glucose levels
Scientific Title
Randomized controlled trials of the effects of food supplementation with resistant starch on intestinal microbiota and postprandial blood glucose levels
Scientific Title:Acronym
Randomized controlled trials of the effects of food supplementation with resistant starch on intestinal microbiota and postprandial blood glucose levels
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect on fecal butyric acid concentration and short-chain fatty acids when the test meal is continuously ingested for 2 weeks, and the effect on the short-term postprandial blood glucose level when the test meal is ingested.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Butyrate-producing bacteria and fatty acids in feces
Postprandial blood glucose
Key secondary outcomes
Subjective questionnaire and dietary survey on defecation status
Area under the blood glucose curve
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
In the butyrate-producing bacteria test in feces, 100 g of resistant starch-added food is ingested once a day as a test meal.
In the postprandial blood glucose level test, 110 g of rice and 100 g of resistant starch-added food are ingested once a day as test meals.
Interventions/Control_2
In the butyrate-producing bacteria test in feces, 100 g of resistant starch-free food is ingested once a day as a control meal.
In the postprandial blood glucose test, take 147 g of rice once a day as a control meal.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who agree with this study and do not meet the exclusion criteria.
Key exclusion criteria
1.Those who are being treated for serious diseases such as diabetes, liver disease, kidney disease, heart disease, digestive system disease, and those who have a history of it.
2.Those with a BMI of 30 or more and impaired glucose tolerance in the past year's test.
3.Those with food allergies.
4.Those who regularly use quasi-drugs, foods for specified health use, health foods and supplements that are thought to affect sugar decomposition, blood sugar level and intestinal environment.
5.Those who plan to significantly change their lifestyle during the exam period.
6.Excessive smokers (21 cigarettes / day or more).
7.Persons whose normal drinking amount exceeds 1000 mL (40 g in terms of alcohol) in terms of beer (5%) per day.
8.Those who are pregnant, breastfeeding or plan to become pregnant or breastfeeding during the test period.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Karasawa |
Organization
Kitasato Junior College of Health and Hygienic Sciences
Division name
Department of Applied Clinical Dietetics
Zip code
9497241
Address
500,KurotsuchiShinden,MinamiUonuma City, Niigata,Japan
TEL
025-779-4511
mkara@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Karasawa |
Organization
Kitasato Junior College of Health and Hygienic Sciences
Division name
Department of Applied Clinical Dietetics
Zip code
9497241
Address
500,KurotsuchiShinden,MinamiUonuma City, Niigata,Japan
TEL
025-779-4511
Homepage URL
mkara@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato Junior College of Health and Hygienic Sciences
Institute
Department
Personal name
Funding Source
Organization
Ingredion Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato Institute Hospital Research Ethics Committee
Address
5-9-1 Shirokane, Minato-ku, Tokyo,Japan
Tel
03-5791-6106
kenkyu@insti.kitasato-u.ac.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
北里大学保健衛生専門学院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | 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
23
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 | 02 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | 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 | 03 | Month | 02 | Day |
Last modified on
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053673
