Tokyo, March 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061018) titled 'A randomized, open-label, crossover comparison study for the effects of consumption of frozen dessert on blood glucose levels' on March 23.

Study Type: Interventional

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

Primary Sponsor: Institute - Morinaga Milk Industry CO., LTD.

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

Objective: Narrative objectives1 - To evaluate the efficacy of frozen dessert in blood glucose levels management in healthy individuals. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Control food -> The test food1 -> The test food2

*Take each test food over five min Interventions/Control_2 - Control food -> The test food2 -> The test food1

*Take each test food over five min

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Men and women aged 20 or more and less than 65 at the time of agreement to participate in this study Key exclusion criteria - 1. Individuals whose fasting blood glucose level is 126 mg/dL or more at screening (Scr)

2. Individuals whose hemoglobin A1c (HbA1c) is 6.5% or more at Scr

3. Individuals who take medicines that may influence the blood glucose level

4. Individuals who are currently taking "Foods for Specified Health Uses" or "Foods with Function Claims"

5. Individuals who are undergoing medical treatment or have a serious medical history of any disease such as liver, kidney, heart, lung, digestive organ, blood, endocrine system, or metabolic system

6. Individuals who have drug allergy or food allergy (such as eggs, milk ingredients, soybeans)

7. Individuals who are pregnant, planning to become pregnant during this study, or lactating

8. Individuals who are collected 400 mL or more of blood due to blood donation within 8 weeks before the agreement to participate in this study

9. Individuals who are dental decay or hypersensitive teeth

10. Individuals who are participating in other clinical trials or plan to participate in another study during this study

11. Individuals who are judged as ineligible to participate in this study based on the results of participant' background, physical finding, consultation, physical examination, and clinical examination, by principal physician or sub-physician Target Size - 18

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 11 Day Date of IRB - 2026 Year 03 Month 11 Day Anticipated trial start date - 2026 Year 03 Month 23 Day Last follow-up date - 2026 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069822

Disclaimer: Curated by HT Syndication.