Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058900) titled 'Safety trial of 12-week continuous intake of the test food' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - others
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the safety of twelve weeks of continuous consumption of the test food in Japanese men and women between the ages of 20 and 65.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Intake of the active food for 12 weeks
Interventions/Control_2 - Intake of the placebo food for 12 weeks
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1.Japanese men and women between 20 and 65 years of age at the time of obtaining written informed consent.
2.Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study in writing.
Key exclusion criteria - 1.Subjects who are taking medication or under medical treatment.
2.Subjects who are under exercise therapy or dietetic therapy.
3.Subjects who have any kind of allergy, such as to food or pollen, regardless of the test food. (Especially subjects with an egg allergy.)
4.Subjects with current or history of drug dependence or alcohol dependence.
5.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past.
6.Subjects with irregular life rhythms due to night shifts or shift work.
7.Subjects with extremely irregular lifestyle habits such as eating and sleeping.
8.Subjects who are or may be of excessive alcohol consumption.
9.Subjects who have an extremely unbalanced diet.
10.Subjects with serious current or past medical conditions such as brain disease, malignancy, immunological disorders, diabetes, liver disease (including hepatitis), kidney disease, heart disease, thyroid disorders, adrenal gland disorders, or other metabolic diseases.
11.Subjects who have been previously advised of abnormalities or concerns regarding liver function parameters (such as gamma-GTP, AST, or ALT) during a health checkup or similar medical examination.
12.Subjects with using health foods, supplements, and medications that reduce fatigue.
13.Subjects who have participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period.
14.Subjects who have collected 200 mL of blood or donated more than 400 mL of blood within 3 months from the date of consent acquisition.
15.Subjects who are planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
16.Subjects who have difficulty in recording compliance with various survey forms.
Target Size - 32
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 07 Day
Date of IRB - 2025 Year 08 Month 22 Day
Anticipated trial start date - 2025 Year 09 Month 02 Day
Last follow-up date - 2026 Year 01 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067359
Disclaimer: Curated by HT Syndication.
