Tokyo, May 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061471) titled 'Safety Study on Excessive Intake of the Test Food
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -' on May 10.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - TES Holdings Co., Ltd.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate the safety of excessive intake of the test food by having subjects consume three times the recommended daily intake for four weeks.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Oral ingestion of a test food (3 packets in a day; 4 weeks).
Interventions/Control_2 - Oral ingestion of a placebo food (3 packets in a day; 4 weeks).
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Healthy men and women aged 20 to 64 at the time of obtaining consent to participate in the study.
2) Individuals who have received a thorough explanation of the study's purpose and content, possess the capacity to consent, have voluntarily applied to participate after fully understanding the study, and are able to provide written consent to participate in the study.
3) Individuals who are able to visit the facility on the designated examination date and undergo the examination.
4) Individuals deemed suitable for participation in the study by the principal investigator.
Key exclusion criteria - Individuals
1) currently suffering from any medical condition and undergoing drug treatment.
2) with a current history of mental illness, sleep disorders, hypertension, diabetes, or dyslipidemia, or a history of severe cases of these conditions.
3) with a history of serious conditions affecting the liver, kidneys, heart, lungs, blood, or digestive system.
4) who regularly take medication or have a history of taking medication for the treatment of medical conditions within the past month (excluding occasional use for conditions such as headaches, menstrual cramps, or colds) .
5) with a BMI of 30 kg/m2 or higher.
6) who may experience allergic reactions to ingredients contained in the test food, or who may experience allergic reactions to other foods or medications.
7) who have donated blood or similar fluids in amounts exceeding 200 mL within the past month, or 400 mL within the past three months.
8) whose daily alcohol consumption exceeds an average of 40 g of alcohol per day for men and 20 g of alcohol per day for women, calculated on a weekly basis.
9) whose daily routines may change during the study period (e.g., night shifts, extended travel) .
10) who currently consume, or have consumed within the past three months, health functional foods, health foods, or supplements on a regular basis, or who plan to consume such products during the study period.
11) who are pregnant, breastfeeding, or may become pregnant, or who intend to become pregnant during the study period.
12) currently participating in another clinical trial, or those who have participated in another clinical trial within the past three months.
13) whose family members or themselves are employed by a company that develops, manufactures, or sells health foods, functional foods, or cosmetics.
14) Any other individuals deemed ineligible for this trial by the principal investigator.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 31 Day
Date of IRB - 2026 Year 04 Month 01 Day
Anticipated trial start date - 2026 Year 05 Month 22 Day
Last follow-up date - 2026 Year 06 Month 24 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069955
Disclaimer: Curated by HT Syndication.
