UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034944 |
|---|---|
| Receipt number | R000039789 |
| Scientific Title | Effect of consuming vegetable juice on postprandial glucose levels |
| Date of disclosure of the study information | 2018/11/21 |
| Last modified on | 2021/11/22 11:13:01 |
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Basic information
Public title
Effect of consuming vegetable juice on postprandial glucose levels
Acronym
Effect of consuming vegetable juice on postprandial glucose levels
Scientific Title
Effect of consuming vegetable juice on postprandial glucose levels
Scientific Title:Acronym
Effect of consuming vegetable juice on postprandial glucose levels
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the efeect of tomato jyuice on postprandial glucose parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incremental area under the glucose curve
Key secondary outcomes
Incremental glucose peak
Standard deviation for blood glucose
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
1.Tomato juice
Participants consume tomato juice at 30 min before rice and examine the blood glucose at 0,30,60,120,180 min after consuming rice and test meal lunch by self-monitoring blood glucose test.
Interventions/Control_2
2.Tomato
Participants consume tomato at 30 min before rice and examine the blood glucose at 0,30,60,120,180 min after consuming rice and test meal lunch by self-monitoring blood glucose test.
Interventions/Control_3
3. Contorol (water)
Participants consume water at 30 min before rice and examine the blood glucose at 0,30,60,120,180 min after consuming rice and test meal lunch by self-monitoring blood glucose test.
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy volunteers
2.Individuals whose written informed consents have been obtained
3.Individuals who are judged appropriate for the study by the principal
Key exclusion criteria
1.Patients with type 1 and type 2 diabetes
2.Treatment with steroid
3.Women with possibility of pregnancy or pregnant
4.Severe health problems not suitable for the study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Saeko |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Women's University
Division name
Food and Nutrition
Zip code
6058501
Address
35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto
TEL
075-531-7128
imais@kyoto-wu.ac.jp
Public contact
Name of contact person
| 1st name | Saeko |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Women's University
Division name
Food and Nutrition
Zip code
6058501
Address
35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto
TEL
075-531-7128
Homepage URL
imais@kyoto-wu.ac.jp
Sponsor or person
Institute
Kyoto Women's University
Institute
Department
Personal name
Funding Source
Organization
Kyoto Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Women's University
Address
35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto
Tel
075-531-7123
imais@kyoto-wu.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
京都女子大学(京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
https://apjcn.nhri.org.tw/server/APJCN/29/3/491.pdf
Publication of results
Published
Result
URL related to results and publications
https://apjcn.nhri.org.tw/server/APJCN/29/3/491.pdf
Number of participants that the trial has enrolled
25
Results
Consuming tomato juice half hour before carbohydrate ameliorates the postprandial blood glucose concentrations, although total amounts of energy and carbohydrate of tomato juice are higher than those of water.
Results date posted
| 2021 | Year | 11 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In this randomized con-trolled cross-over study, 25 healthy women, age 21.6 years, HbA1c 5.3%, completed the study.
Participant flow
We recruited volunteers as research participants in our University. Exclusion criteria are as follows. People with type 1 and type 2 diabetes, taking drugs that affect blood glucose concentrations, pregnant or willing to become pregnant, smoking more than 40 cigarettes per day or drinking 50 ml alcohol per day, people with mental illness, people who were considered inappropriate for the study by the doctor.
Adverse events
No adverse events were shown in this study.
Outcome measures
Incremental blood glucose concentrations, IGP, IAUC for glucose
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 20 | Day |
Last modified on
| 2021 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039789
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/11/22 | Tomato juice.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
