UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050268 |
|---|---|
| Receipt number | R000055488 |
| Scientific Title | Effect of consuming vegetable juice with lemon and omega 3 oil on postprandial glucose concentration |
| Date of disclosure of the study information | 2023/02/09 |
| Last modified on | 2026/08/12 10:52:29 |
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Basic information
Public title
Effect of consuming vegetable juice with lemon and omega 3 oil on postprandial glucose concentration
Acronym
Effect of consuming vegetable juice with lemon and omega 3 oil on postprandial glucose concentration
Scientific Title
Effect of consuming vegetable juice with lemon and omega 3 oil on postprandial glucose concentration
Scientific Title:Acronym
Effect of consuming vegetable juice with lemon and omega 3 oil on postprandial glucose concentration
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the effect of vegetable juice with lemon and omega 3 oil on postprandial glucose parameters and insulin concentrations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incremental blood glucose concentrations
Key secondary outcomes
Postprandial insulin concentrations
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Participants consume vegetable juice with lemon and omega 3 oil before rice and examine the blood glucose and insulin concentrations.
Interventions/Control_2
Participants consume vegetable juice before rice and examine the blood glucose and insulin concentrations.
Interventions/Control_3
Participants consume water before rice and examine the blood glucose and insulin concentrations.
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
Healthy volunteers
Individual whose written informed consents have been obtained
Individuals who are judged appropriate for the study by the principal
Key exclusion criteria
Patients with type 1 and type 2 diabetes
Treatments with steroid
Women with possibility of pregnant of pregnant
Severe health problems not suitable fot 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
Department of Food and Nutrition
Zip code
6058501
Address
35, Imakumano, Kitahiyoshi-cho, HIgashiyama-ku, Kyoto
TEL
+81755317128
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
Department of Food and Nutrition
Zip code
6058501
Address
35, Imakumano, Kitahiyoshi-cho, HIgashiyama-ku, Kyoto
TEL
+81755317128
Homepage URL
imais@kyoto-wu.ac.jp
Sponsor or person
Institute
Department of Food and Nutrition, Kyoto Women's University
Institute
Department
Personal name
Funding Source
Organization
Department of Food and Nutrition, Kyoto Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Women's University
Address
35, Imakumano, Kitahiyoshi-cho, HIgashiyama-ku, Kyoto
Tel
+81755317128
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
| 2023 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/40301054/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40301054/
Number of participants that the trial has enrolled
21
Results
Adding lemon and n-3 PUFA-rich oil to tomato juice before carbohydrate meal can be practical method to lower early postprandial glucose and insulin responses in young healthy women.
Results date posted
| 2026 | Year | 08 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 06 | Month | 16 | Day |
Baseline Characteristics
The aim was to evaluate the acute effect of drinking tomato juice preloaded with lemon and perilla oil 10 min before consuming carbohydrate on postprandial blood glucose, insulin, and lipids concentrations in young healthy women. In this randomized controlled crossover study, 21 women (age 21.1 years, HbA1c 5.2%, mean) consumed either 200 g of tomato juice, tomato juice with 10 g of lemon juice and 5 g of perilla oil (n-3 PUFA-rich oil), or water 10 min before consuming 200 g of boiled white rice for 3 separate days.
Participant flow
The blood parameters were measured at 0, 30, 60, and 120 min after carbohydrate consumption and compared among 3 d. The plasma glucose at 30 min in tomato juice with lemon/n-3 PUFA-rich oil was significantly lower than that of water and tended to be lower than that of tomato juice. The serum insulin at 30 min was also significantly lower in tomato juice with lemon/n-3 PUFA-rich oil than that of tomato juice.
Adverse events
No adverse effect was observed.
Outcome measures
Blood glucose and insulin concentration at pre- and post-meal. Incremental area under the glucose and insulin curve at post-meal.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 10 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 20 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 08 | Day |
Last modified on
| 2026 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055488
