UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057493 |
|---|---|
| Receipt number | R000065679 |
| Scientific Title | Crossover Comparison Study - Verification of the Effect of Okra Pickles in Preventing Elevated Blood Glucose Levels (Pickles First Effect) |
| Date of disclosure of the study information | 2025/04/03 |
| Last modified on | 2025/04/02 12:19:43 |
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Basic information
Public title
Crossover Comparison Study - Verification of the Effect of Okra Pickles in Preventing Elevated Blood Glucose Levels (Pickles First Effect)
Acronym
Crossover Comparison Study - Verification of the Effect of Okra Pickles in Preventing Elevated Blood Glucose Levels (Pickles First Effect)
Scientific Title
Crossover Comparison Study - Verification of the Effect of Okra Pickles in Preventing Elevated Blood Glucose Levels (Pickles First Effect)
Scientific Title:Acronym
Crossover Comparison Study - Verification of the Effect of Okra Pickles in Preventing Elevated Blood Glucose Levels (Pickles First Effect)
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the effect of okra pickles in suppressing blood sugar levels (pickle first effect).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Postprandial blood glucose level
2)Blood insulin levels
3)HbA1c
Key secondary outcomes
1)Serum electrolyte concentrations (Na, K, Cl-)
2)BMI
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingesting 150g of rice followed by 60g of pickled okra 5 minutes later
Interventions/Control_2
Ingesting 60g of pickled okra followed by 150g of rice 5 minutes later
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Men and women aged 20 to 50 at the time of consent
2)Those who feel that they consume too little vegetables in their daily lives
3)Subjects who have fully understood the purpose of participating in this clinical study and have given their voluntary written consent
Key exclusion criteria
1)with following diseases
Type2 diabetes,glucose tolerance,dyslipidemia,hypertension(exclude grade1 hypertension),hyperuricemia,gout,myocardial infarction,angina pectoris,cerebral thrombosis,transient ischemic attack,fatty liver(nonalcoholic fatty liver),menstrual abnormalities,pregnancy complications(pregnant with hypertension,gestational diabetes),sleep apnea syndrome,obesity hypoventilation syndrome, osteoarthritis(knee,hip),spondylosis,low back pain,obesity-related kidney disease,other chronic diseases(digestive,cardiac,liver,kidney,neurological,stroke,rheumatism,etc.)
2)who history or complications of malignancy
3)who family history of diabetes or glucose tolerance
4)who treat by drug,device,rehabilitation,etc.,regardless of seasonal,chronic,sudden illness at screening
5)who medical history in 3months
6)who BMI is less than 18.5 and over 25kg/m2
7)who surgery in past
8)with food allergy or sensitive or specific constitutions
9)who on drug treat
10)who experienced feel unwell or worse physical condition by blood drawn past
11)who donated 200mL within 4weeks or component donated within 2weeks prior to intake
12)Women who donated 400mL within 16weeks prior to intake
13)Men who donated 400mL within 12weeks prior to intake
14)who taking Over-the-counter drug,supplements,or foods for specified health uses
15)who wish to pregnant during the study
16)who breastfeed,pregnant and plan to pregnant
17)judged by the principal to require treat for mental illness
18)who smoke or alcohol excessively
19)who nightwork,cannot take regular off,irregular lifestyles
20)who likely to experience major changes in living environment(home,work,etc.)during the study(moving,job transfer,longtravel,etc.)or in their eating or exercise habits
21)who currently participating other study,participated within 4weeks of WEB screening,or scheduled to participate other study during the study
22)who cannot comply management matters during the study
23)judged inappropriate for the study by principal
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Research Unit, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Hoshino |
Organization
Macromill, Inc.
Division name
Clinical Research Unit, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japn
TEL
03-6716-0700
Homepage URL
t_hoshino@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Tokai Pickling Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Tsukiji Futaba Clinic
Address
Tsukiji 1-9-9, Chuou-ku, Tokyo, Japan
Tel
03-6226-5812
tohru@hikobae.net
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 | 03 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 05 | 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 | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065679
