Tokyo, Aug. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061572) titled 'Non-randomized, open-label crossover comparative trial on the effects of food intake on blood glucose levels' on Aug. 31.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Hayashikane Sangyo Co., Ltd.
Condition:
Condition - N/A(healthy adults)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluate the time course of blood glucose levels due to food intake.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Single intake of test food > Washout period > Non-intake
Interventions/Control_2 - Non-intake > Washout period > Single intake of test food
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Male or female Hayashikane Sangyo Co., Ltd. employees working at headquarters, aged 20-64 at the time of obtaining consent.
2. Those who have received a full explanation of the study content, fully understood it, and voluntarily given written consent to participate in the study.
3. Those who are not shift workers or night shift workers.
4. Those who are not participating in any other clinical trials.
5. Those who do not have allergies to the ingredients of the test product or the challenge food.
6. Those who do not regularly take any medications that may affect blood glucose levels.
7. Those who can quit smoking from the day of each efficacy evaluation until the end of measurement.
8. From the day before each efficacy evaluation until the end of measurement. Those who can abstain from alcohol immediately
9. Those who are not pregnant
10. Those who are not breastfeeding
11. Those who can stop taking health foods and supplements that may affect blood glucose levels from one week before the start of the efficacy evaluation until the last day of the efficacy evaluation
12. Those who are not anemic and can undergo frequent blood sampling (2 ml x 4 times per day for efficacy evaluation)
13. Those who have not had more than 200 ml of blood drawn or donated blood components within one month prior to the date of consent
14. Those who have never been diagnosed with diabetes
15. Those with chronic digestive diseases
16. Those who have never undergone gastrointestinal surgery
Key exclusion criteria - 1. Pregnant individuals or those who may become pregnant during the study period, and breastfeeding individuals.
2. Individuals who have taken any supplements that affect blood glucose levels (excluding the test product) between one week before the start of the study and the last day of the study.
3. Individuals deemed unsuitable as study participants by the principal investigator.
4. Individuals who have eaten or drunk anything (excluding water, the test product, and the load food during the efficacy confirmation study) between 9 PM the day before the efficacy confirmation study and its end.
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 24 Day
Date of IRB - 2026 Year 04 Month 30 Day
Anticipated trial start date - 2026 Year 06 Month 01 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=R000070450
Disclaimer: Curated by HT Syndication.
