Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059320) titled 'Safety Confirmation Test through Continuous Intake of Test Food
-Randomized, placebo-controlled, double-blind, parallel-group comparative trial-' on Oct. 7.
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 - This study aims to confirm the safety of the test food when consumed for four weeks.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Oral intake of the test food (1 bottle in a day; 4 weeks).
Interventions/Control_2 - Oral intake of the placebo food (1 bottle in a day; 4 weeks).
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Healthy males and females aged 20 years or older but under 65 years at the time of obtaining consent to participate in the trial.
2) Healthy individuals without chronic physical conditions, including skin diseases.
3) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer for participation after thorough understanding, and can provide written consent to participate in this trial.
4) Individuals who can attend the designated examination date and undergo the examination.
5) Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria - 1) Individuals currently suffering from any disease and undergoing drug treatment.
2) Individuals with a current medical history involving the digestive organs, liver, kidneys, heart, lungs, mental disorders, sleep disorders, blood disorders, etc., or individuals with a history of serious diseases.
3) Individuals who habitually took medication for disease treatment within the past month (excluding occasional use for headaches, menstrual pain, colds, etc.).
4) Individuals with severe anemia.
5) Individuals with a BMI below 18.5 kg/m2 or above 30 kg/m2.
6) Individuals with systolic blood pressure of 140 mmHg or higher, diastolic blood pressure of 90 mmHg or higher, or pulse rate of 85 beats per minute or higher.
7) Individuals who have donated blood exceeding 200 mL within the past month or 400 mL within the past three months.
8) Individuals who have previously experienced discomfort or deterioration in physical condition following blood collection.
9) Individuals with drug (including alcohol) or food allergies.
10) Individuals regularly consuming specific health foods, foods with functional claims, or health supplements (excluding those who can suspend intake during the trial period at the time of consent).
11) Individuals whose average weekly alcohol consumption exceeds 40g/day for men or 20g/day for women (pure alcohol equivalent).
12) Individuals whose lifestyle may change during the trial period (e.g., due to extended travel).
13) Individuals who are pregnant, breastfeeding, or who may become pregnant during the trial period.
14) Individuals currently participating in another human clinical trial, or individuals who have completed another human clinical trial within the past 3 months.
15) Individuals whose self or family members are employed by companies developing, manufacturing, or selling health/functional foods or cosmetics.
16) Other individuals deemed unsuitable for this trial by the Principal Investigator.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 09 Day
Date of IRB - 2025 Year 09 Month 11 Day
Anticipated trial start date - 2025 Year 10 Month 18 Day
Last follow-up date - 2025 Year 11 Month 19 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067600
Disclaimer: Curated by HT Syndication.
