Tokyo, Oct. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059387) titled 'Human Safety Evaluation of Excessive Intake of the Test Food
-A randomized, double-blind, placebo-controlled, parallel-group trial-' on Oct. 19.
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 is to confirm the safety of the test food when consumed continuously for four weeks by healthy men and women.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Oral intake of the test food (1 packet in a day; 4 weeks).
Interventions/Control_2 - Oral intake of the placebo food (1 packet in a day; 4 weeks).
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1) Individuals aged between 18 and 65 years old at the time of obtaining consent to participate in the study.
2) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
Key exclusion criteria - 1) Individuals currently suffering from any chronic disease and receiving drug treatment.
2) Individuals with a history of serious illnesses.
3) Individuals who are unable to participate in the study due to liver, kidney, or heart disease, respiratory disorders, endocrine disorders, metabolic disorders, neurological disorders, impaired consciousness, diabetes, or other illnesses.
4) Individuals with a history of gastrointestinal diseases or gastrointestinal surgery that affect digestion and absorption (excluding appendicitis) .
5) Individuals with a current or past history of drug or food allergies.
6) Individuals with a systolic blood pressure of less than 90 mmHg.
7) Individuals with severe anemia.
8) Individuals who have donated more than 200 mL of blood in the past month or more than 400 mL in the past three months.
9) Individuals who have previously experienced ill health or worsening physical conditions after blood collection.
10) Individuals who regularly consume foods for specified health uses, foods with functional claims, or health foods.
11) Individuals who are pregnant, lactating, or may become pregnant.
12) Individuals who are heavy smokers (average smoking of 21 or more cigarettes per day).
13) Individuals whose daily alcohol intake exceeds 60 g/day of pure alcohol per week.
14) Individuals with a history or current medical history of drug or alcohol dependence.
15) Individuals who may change their lifestyle during the study period (night shifts, long-term travel, etc.).
16) Individuals currently participating in a study involving the intake of other foods or medications, or the application of cosmetics or medications, within the last four weeks of completing a study, or individuals who intend to participate.
17) Individuals judged inappropriate for the study by the principal.
Target Size - 48
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 11 Day
Date of IRB - 2025 Year 09 Month 11 Day
Anticipated trial start date - 2025 Year 10 Month 29 Day
Last follow-up date - 2025 Year 12 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067603
Disclaimer: Curated by HT Syndication.
