UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051648 |
|---|---|
| Receipt number | R000058936 |
| Scientific Title | Examination of suppressing effect of coconut butter in postprandial hyperglycemia |
| Date of disclosure of the study information | 2023/07/19 |
| Last modified on | 2024/01/17 15:37:34 |
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Basic information
Public title
Examination of suppressing effect of coconut butter in postprandial hyperglycemia
Acronym
blood glucose measurement
Scientific Title
Examination of suppressing effect of coconut butter in postprandial hyperglycemia
Scientific Title:Acronym
postprandial blood glucose measurement
Region
| Japan |
Condition
Condition
postprandial hyperglycemia
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will consider about the effect of fat in coconut to suppression of postprandial hyperglycemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
blood glucose level 120 minutes after test diet ingestion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
control 150g boiled rice + 7 crackers
test1 150g boiled rice + 7 crackers + 18g coconut butter
test2 150g boiled rice + 7 crackers + 13.5g coconut butter
test3 150g boiled rice + 7 crackers + 9g coconut butter
test4 150g boiled rice + 7 crackers + 13.5g margarine
test5 150g boiled rice + 7 crackers + 18g margarine
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
subjects: healthy adults (around 20 years old)
Key exclusion criteria
subjects of low blood pressure, anemia, food allergy and poor physical condition
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nishi |
Organization
Tenshi College
Division name
Department of Nutrition, Faculty of Nursing and Nutrition
Zip code
065-0013
Address
Kita-13, Higashi-3, Higashi-ku, Sapporo, Japan
TEL
011-741-1051
nishi@tenshi.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nishi |
Organization
Tenshi College
Division name
Department of Nutrition, Faculty of Nursing and Nutrition
Zip code
065-0013
Address
Kita-13, Higashi-3, Higashi-ku, Sapporo, Japan
TEL
011-741-1051
Homepage URL
nishi@tenshi.ac.jp
Sponsor or person
Institute
Tenshi College
Institute
Department
Personal name
Funding Source
Organization
Tenshi College
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tenshi College
Address
Kita-13, Higashi-3, Higashi-ku, Sapporo, Japan
Tel
011-741-1051
yanagisawa.ken@tenshi.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
天使大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 19 | 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
11
Results
Blood glucose level after 15 and 30min eating 9g and 13.5g of coconut butter with boiled rice and cracker showed lower than the control value at the same time, significantly. In contrast, blood glucose level after 15, 30, 45 and 60min eating 18g of coconut butter and margarine showed lower than the control value at the same time, significantly.
Results date posted
| 2024 | Year | 01 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy 10 women (21 - 22 years old), body shape: normal, food allergy: no
Participant flow
Adverse events
Outcome measures
Fasting and postprandial blood glucose level (mg/dL, mean+SE)
control: fasting 92.7+1.8, 15min 116.2+4.2, 30min 156.2+6.0, 45min 169.4+7.3, 60min 161.0+8.0, 90min 133.9+5.4, 120min 124.1+5.8
9g coconut butter: fasting 88.7+2.7, 15min 106.0+2.8*,30min 137.7+4.6*,45min 153.5+8.4 60min 151.3+8.1, 90min 127.6+7.8, 120min 125.2+6.2
13.5g coconut butter: fasting 92.8+2.3, 15min 107.4+3.3*,30min 136.1+5.8*,45min 155.1+9.2 60min 152.8+8.1, 90min 142.1+10.9,120min 135.1+9.4
18g coconut butter: fasting 93.1+1.6, 15min 113.7+4.0*,30min 130.8+5.5*,45min 140.8+4.7* 60min 133.1+7.2*,90min 134.9+10.1,120min 126.7+8.0
13.5g margarine: fasting 89.5+2.0, 15min 111.1+5.3, 30min 149.7+7.0, 45min 154.7+5.7 60min 143.3+6.8, 90min 121.2+5.6, 120min 116.6+5.1
18g margarine: fasting 89.6+2.4, 15min 109.8+2.3*,30min 143.3+6.1*,45min 142.1+7.9* 60min 135.9+6.7*,90min 130.8+5.2, 120min 122.0+5.5
*: significantly different to the value of control at the same time (p < 0.05)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 14 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 14 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 14 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058936
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