Tokyo, May 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061738) titled 'Safety Study on Long-Term Consumption of a Test Food
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -' on May 30.
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 the test food when consumed over a 12-week period.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Oral intake of the test food (6 pills in a day; 12 weeks).
Interventions/Control_2 - Oral intake of the placebo food (6 pills in a day; 12 weeks).
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Males and females aged 20-64 years.
2) Individuals whose written informed consent has been obtained.
3) Individuals who can come to the designated venue for this study and be inspected.
4) Individuals judged appropriate for the study by the principal.
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 05 Month 25 Day
Date of IRB - 2026 Year 05 Month 25 Day
Anticipated trial start date - 2026 Year 06 Month 06 Day
Last follow-up date - 2026 Year 09 Month 05 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070536
Disclaimer: Curated by HT Syndication.
