Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063083) titled 'Safety trial of overdose of the test food' on Sept. 30.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - MIS Co., Ltd.
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the safety of four weeks of overdoes 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 4 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 an allergy or hypersensitivity to pine needles, pine needle tea, pine needle extracts, pine nuts, or any other food or ingredient derived from plants of the Pinus genus, or who have a history of experiencing adverse health effects after consuming such products.
4.Subjects who have a history of allergy or hypersensitivity to any ingredients contained in the test food, including pine needle hot-water extract, excipients, capsule coating materials, or other components.
5.Subjects who have any kind of allergy, such as to food or pollen, regardless of the test food. (Especially subjects with an egg allergy.)
6.Subjects with current or history of drug dependence or alcohol dependence.
7.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.
8.Subjects with irregular life rhythms due to night shifts or shift work.
9.Subjects with extremely irregular lifestyle habits such as eating and sleeping.
10.Subjects who are or may be of excessive alcohol consumption.
11.Subjects who have an extremely unbalanced diet.
12.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.
13.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.
14.Subjects with using health foods, supplements, and medications that reduce fatigue.
Target Size - 12
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 10 Day
Date of IRB - 2026 Year 09 Month 17 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2026 Year 12 Month 18 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072213
Disclaimer: Curated by HT Syndication.
