Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062751) titled 'Consumer Survey on the Blood Sugar Raising Effects of Our Company's Cheesecake and Pudding' on Aug. 31.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Bi-ba Coporation
Condition:
Condition - Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Verification That Blood Glucose Levels Rise Gradually After Consumption of Our Company's Cheesecake and Pudding
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Consume the control diet twice a week and each of the four test foods once a week
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - 1. Subjects aged 40 to 59 as of April 1 2026.
2. Individuals who have not been identified as having impaired glucose tolerance in previous tests.
3. People with BMI between 18.5 and 24.9.
4. Individuals who prior to participating in the main study have received an explanation of the study understand its content and agree with its purpose and individuals who can obtain written informed consent from the research participants themselves.
5. Individuals who are not currently consuming or who can maintain the same types and frequency of consumption as they had prior to the study period of foods that may affect blood glucose levels such as products containing resistant dextrin including foods for specified health uses foods with functional claims and dietary supplements.
Key exclusion criteria - 1. Subjects with serious cardio vascular, hepatic renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders.
2. Individuals with a fasting blood glucose level of 126 mg/dL or higher, or an HbA1c level of 6.5% or higher.
3. Subjects receiving treatment for a gastrointestinal disease currently or those who have had.
4. Subjects with an allergy to the test food.
5. Individuals who regularly use pharmaceuticals or quasi drugs that affect blood sugar levels, such as those containing vasoconstrictors or licorice.
6. Subjects who plan to make significant changes to their lifestyle (e.g. diet, sleep, exercise) during the study period.
7. Subjects with smoking habits.
8. Subjects with high alcohol consumption (60g or more of pure alcohol per day).
9. Subjects with irregular lifestyles due to night shifts.
10. Female subjects who are pregnant or lactating, or intending to become pregnant during the study.
11. Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study.
12. Subjects deemed unsuitable by the investigator.
Target Size - 25
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 28 Day
Date of IRB - 2026 Year 08 Month 13 Day
Anticipated trial start date - 2026 Year 09 Month 22 Day
Last follow-up date - 2026 Year 11 Month 25 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071846
Disclaimer: Curated by HT Syndication.