Tokyo, Sept. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062784) titled 'Exploratory human study to verify the postprandial blood glucose suppression effect and second-meal effect of food containing cactus' on Sept. 2.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Biosis Lab Co., Ltd.

Condition: Condition - Healthy Adults Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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

Eligibility: Age-lower limit - 20 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 Size - 24

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071884

Disclaimer: Curated by HT Syndication.