Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058907) titled 'Effect of test food consumption on postprandial blood glucose levels in healthy subjects' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Other
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effect of single dose consumption of the test meal on blood glucose elevation at the next meal in Japanese men and women between the ages 20-65 years.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Single intake of active food - Washout period - Non-intake
Interventions/Control_2 - Non-intake - Washout period - Single intake of active food
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1.Japanese male and female subjects between the ages of 20 and 65 at the time of written consent.
2.Subjects who are blood glucose levels are within the normal range (less than 126 mg/dL at fasting) at the time of health chack up.
3. Subjects who have received a full explanation of the purpose and content of the study, have the ability to consent, understand the study well, and have volunteered to participate in the study and have agreed to participate in the study in writing.
Key exclusion criteria - 1.Subjects who are taking medication or under medical treatment.
2.Subjects who are under exercise therapy or dietetic therapy.
3.Subjects who have developed allergies as for the foods test.
4.Subjects with current or history of drug dependence or alcohol dependence.
5.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past.
6.Subjects with irregular life rhythms due to night shifts or shift work.
7.Subjects with extremely irregular lifestyle habits such as eating and sleeping.
8.Subjects who have an extremely unbalanced diet.
9.Subjects who have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, diabetes mellitus, liver diseases (hepatitis), kidney diseases, heart diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases.
10.Subjects with a body mass index (BMI) exceeding 30.
11.Subjects who use health foods and medicines that contain ingredients that affect the trial
12.Subjects who have participated in other clinical trials (research) within 3 months retrospectively from the date of obtaining consent, or those who have plans to participate in other clinical trials (research) during the study period.
13.Subjects who have collected more than 200 mL of blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent.
14.Subjects who are currently pregnant or breastfeeding. or who are likely to become so during the study period.
15.Subjects who are judged to be inappropriate as subjects based on clinical laboratory test values and measured values at the time of SCR.
16.Subjects who are considered as an inappropriate candidate by the doctor in charge.
Target Size - 21
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 07 Day
Date of IRB - 2025 Year 07 Month 17 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2025 Year 09 Month 11 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067130
Disclaimer: Curated by HT Syndication.
