Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059309) titled 'Exploratory study on blood glucose response after Glucolacto-oligosaccharides intake' on Oct. 16.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Meiji Co., Ltd
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effect of consumption of Glucolacto-oligosaccharides on blood glucose
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Take the test food 1 containing Glucolacto-oligosaccharides within 5 min.
Interventions/Control_2 - Take the placebo food 1 containing sucrose within 5 min.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male
Key inclusion criteria - 1. Subjects who are Japanese men aged 20 to below 65 years at the time of consent acquisition.
2. Subjects whose BMI are 18.5 or more and less than 25.
3. Subjects whose fasting blood glucose level are less than 126 mg/dL on SCR blood test.
4. Subjects who can obtaining time-dependently blood sampling.
5. Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria - 1. Subjects who have severe or progressive diseases, such as cardiac-, hepatic-, kidney-, heart-, lung- and digestive- diseases, diabetes mellitus, rheumatoid arthritis, neurological disease, psychiatric disorders, endocrine disease, and other diseases.
2. Subjects who are taking medications for diabetes mellitus.
3. Subjects who have food allergy.
4. Subjects who are aware of lactose intolerance.
5. Subjects with a history of stomach or small intestine resection (excluding polypectomy and minor surgery).
6. Subjects who are heavy drinkers with an average daily intake of over 60 g in terms of pure alcohol.
7. Subjects with Tmax of postprandial blood glucose levels at 90min.
8. Subjects who are current smoker.
9. Subjects who fast or miss a meal (4 or more days a week) on a regular basis.
10. Subjects with carbohydrate-restricted diet (1 or more days a week).
11. Subjects who donate blood more than 200 mL of blood and/or blood components within 1 month prior to the date of obtaining informed consent.
12. Subjects who have participated in other clinical trials within 1 month prior to the date of obtaining informed consent (excluding observation study).
13. Subjects who are judged unsuitable for this study by principal investigator or sub-investigator.
Target Size - 16
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 08 Month 22 Day
Date of IRB - 2025 Year 08 Month 29 Day
Anticipated trial start date - 2025 Year 09 Month 08 Day
Last follow-up date - 2025 Year 11 Month 10 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067490
Disclaimer: Curated by HT Syndication.
