Tokyo, Feb. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060691) titled 'Study of the effects on blood biochemical data after ingestion of foods' on Feb. 17.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Morinaga & Co., Ltd.
Condition:
Condition - This study aims to evaluate the effect on blood biochemical data after ingestion of foods
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate the effect on blood biochemical data after ingestion of foods
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Oral ingestion of the test food 1
Interventions/Control_2 - Oral ingestion of the test food 2
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male
Key inclusion criteria - 1 Japanese males who are between 20 and 60 years of age at the time of obtaining consent
2 Participants who are able to come to the clinic on the designated date and have multiple blood samples taken (7 samples/day x 2 observations)
3 Healthy participants* *"Healthy" in this study refers to those who have no serious organ damage or disease and are not receiving any treatment related to them or any kind of drug therapy. Whether or not a participant is "healthy" is based on the participant's report at the start of the study.
4 Participants who have been fully informed of the purpose and content of the study, have the capacity to consent, understands the study, voluntarily volunteers to participate in the study, and are able to give written consent to participate in the study.
5 Participants with a BMI 20 to 24.9 (male)
Key exclusion criteria - Participants
1 with chronic diseases or disorders of the liver, biliary tract, digestive system, circulatory system, respiratory system, kidney, urinary system, mental, nervous system, or blood system
2 who are allergic to medicines or food.
3 who have a smoking habit.
4 who may change their lifestyle during the study period (e.g., work at night, travel for long periods, etc.)
5 who are going to the hospital, taking medication, or undergoing medical treatment
6 with lifestyle-related diseases (diabetes, hypertension, dyslipidemia, etc.) such as those whose fasting blood glucose level is in the diabetic range (fasting blood glucose of 126 mg/dL or higher) or those who have been diagnosed in the past
7 with severe anemia
8 who dislike chocolate.
9 who have a habit of taking drugs for the purpose of disease treatment in the past month (excluding those who have taken drugs for headache, menstrual cramps, common cold, etc.).
10 who have received treatment involving hospitalization within the past 6 months.
11 who are aliquor heavy drinkers (more than 60g of alcohol per day e.g., 1500ml of beer, 2.5 g of sake, approximately 200ml of whiskey straight)
12 who are currently participating in another clinical trial, will participate in another clinical trial within 4 weeks after the completion of the trial, or will participate in another clinical trial after agreeing to participate in the said trial.
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 12 Day
Date of IRB - 2026 Year 02 Month 12 Day
Anticipated trial start date - 2026 Year 03 Month 09 Day
Last follow-up date - 2026 Year 03 Month 26 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069421
Disclaimer: Curated by HT Syndication.
