UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062784 |
|---|---|
| Receipt number | R000071884 |
| Scientific Title | Exploratory human study to verify the postprandial blood glucose suppression effect and second-meal effect of food containing cactus |
| Date of disclosure of the study information | 2026/09/02 |
| Last modified on | 2026/09/02 16:12:54 |
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Basic information
Public title
Exploratory human study to verify the postprandial blood glucose suppression effect and second-meal effect of food containing cactus
Acronym
Exploratory human study to verify the postprandial blood glucose suppression effect and second-meal effect of food containing cactus
Scientific Title
Exploratory human study to verify the postprandial blood glucose suppression effect and second-meal effect of food containing cactus
Scientific Title:Acronym
Exploratory human study to verify the postprandial blood glucose suppression effect and second-meal effect of food containing cactus
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of single ingestion of cactus food compared with control food on lowering blood glucose iAUC from 0 to 120 minutes after breakfast, and the effect of ingestion at breakfast on blood glucose iAUC from 0 to 120 minutes after lunch on the same day (second-meal effect) exploratorily.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incremental area under the curve of blood glucose (blood glucose iAUC) after breakfast and lunch (0 to 120 minutes after breakfast and lunch)
Key secondary outcomes
Blood glucose Cmax, Delta Cmax, and Tmax after each challenge meal (0 to 120 minutes after each challenge meal), blood glucose levels at each evaluation point (15, 30, 45, 60, 90, and 120 minutes after breakfast and lunch), total daytime blood glucose iAUC
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake 120 g/day of test food in juice form 10 minutes before or at the same time as breakfast (challenge meal).
Interventions/Control_2
No intake
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Persons who are male or female aged 20 to 64 years old at the time of obtaining consent.
2. Persons whose BMI is approximately 18.5 to 30.0 kg/m2.
3. Persons who have not been diagnosed with diabetes or are not receiving diabetes treatment.
4. Persons with a priority for those whose postprandial blood glucose tends to rise (e.g., fasting blood glucose 100 to 125 mg/dL, HbA1c 5.6 to 6.4%, history of high casual or postprandial blood glucose, family history, visceral fat obesity, etc.).
5. Persons who can agree to restrictions on meals, exercise, and alcohol consumption on the day before the test day, fasting for 10 hours or more, and multiple blood sampling or finger pricks.
6. Persons who can discontinue the intake of cactus foods and supplements that may affect blood glucose response (indigestible dextrin, inulin, beta-glucan, etc.) during the study period.
Key exclusion criteria
1. Persons who are suspected of having, or have a medical history of, or are currently visiting a hospital for, or have a current medical history of severe gastrointestinal, liver, kidney, cardiovascular, blood, or endocrine diseases, or malignant neoplasms.
2. Persons who are using diabetes medications (insulin, GLP-1 receptor agonists, SGLT2 inhibitors, alpha-glucosidase inhibitors, etc.).
3. Persons who are suspected of having diabetic type.
4. Persons who are continuously using drugs that affect blood glucose levels, such as corticosteroids, antipsychotics, diuretics, etc.
5. Persons who have a past or current medical history of hypoglycemic attacks, syncope, blood coagulation disorders, or severe anemia, or those who have difficulty in blood sampling.
6. Persons who are allergic to cactus, fruits, food additives, or test food ingredients.
7. Persons who usually consume a large amount of test food.
8. Persons who routinely use medicines or functional foods for health uses (specified health foods, functional foods, and functional nutrition foods) that may affect blood glucose levels.
9. Persons who have participated in other studies within 1 month before the start of the study, or who plan to participate in other studies after consenting to this study.
10. Persons who are judged as ineligible by the principal investigator.
11. Persons who are breastfeeding, pregnant, or planning/hoping to become pregnant during the study period.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
Biosis Lab Co., Ltd.
Division name
President and CEO
Zip code
470-1192
Address
11-506, 1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
takumitochiobiz@gmail.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
Biosis Lab Co., Ltd.
Division name
President and CEO
Zip code
470-1192
Address
11-506, 1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
Homepage URL
takumitochiobiz@gmail.com
Sponsor or person
Institute
Biosis Lab Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Watahan Trading 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2026 | Year | 09 | Month | 02 | 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
| 2026 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071884
