UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057672 |
|---|---|
| Receipt number | R000065899 |
| Scientific Title | Effect of lemon juice intake and meal intake order on postprandial blood glucose levels |
| Date of disclosure of the study information | 2025/04/21 |
| Last modified on | 2025/04/21 18:28:23 |
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Basic information
Public title
Effect of lemon juice intake and meal intake order on postprandial blood glucose levels
Acronym
Lemon juice, meal intake order and postprandial blood glucose
Scientific Title
Effect of lemon juice intake and meal intake order on postprandial blood glucose levels
Scientific Title:Acronym
Lemon juice, meal intake order and postprandial blood glucose
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether consumption of lemon juice is effective in suppressing postprandial blood glucose elevation, and whether consumption of vegetables and meat before consumption of white rice is effective in suppressing postprandial blood glucose elevation.
Basic objectives2
Others
Basic objectives -Others
Physiological response
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fasting and postprandial subcutaneous glucose levels (every minute up to 180 minutes after a meal)
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Each subject consumes the following three meals at three different breakfasts:
Meal 1: 150 g white rice with 200 mL lemon water (12 g lemon juice solution)
Meal 2: 150 g white rice with 200 mL water
Meal 3: 150 g white rice with 200 mL vinegar water (15 g rice vinegar solution)
Each subject further consumes the test meal of a) 150 g white rice, b) 170 g vegetables and 12 g mayonnaise, and c) 45 g salad chicken in another three different breakfasts in the following three orders:
Order 1: a) (5 min)-b) (5 min)-c) (5 min)
Order 2: b) (5 min)-c) (5 min)-a) (5 min)
Order 3: a), b), c) at the same time (15 minutes)
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Students and faculty of the University of Niigata Prefecture
Key exclusion criteria
Diabetes, medications that affect blood glucose levels, pregnancy and bleeding disorders
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Naohito |
| Middle name | |
| Last name | Tanabe |
Organization
University of Niigata Prefecture
Division name
Department of Health and Nutrition, Faculty of Human Life Studies
Zip code
950-8680
Address
471 Ebigase, Higashi-ku, Niigata City, Niigata Prefecture, Japan
TEL
025-368-8240
tanabe@unii.ac.jp
Public contact
Name of contact person
| 1st name | Naohito |
| Middle name | |
| Last name | Tanabe |
Organization
University of Niigata Prefecture
Division name
Department of Health and Nutrition, Faculty of Human Life Studies
Zip code
950-8680
Address
471 Ebigase, Higashi-ku, Niigata City, Niigata Prefecture, Japan
TEL
025-368-8240
Homepage URL
tanabe@unii.ac.jp
Sponsor or person
Institute
University of Niigata Prefecture
Institute
Department
Personal name
Naohito Tanabe
Funding Source
Organization
Self-funding
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
Ethics Committee, University of Niigata Prefecture
Address
471 Ebigase, Higashi-ku, Niigata City, Niigata Prefecture, Japan
Tel
025-270-1300
unp@unii.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 08 | 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
| 2025 | Year | 04 | Month | 21 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065899
