The study to evaluate the effect of the test food on fatigue due to exercise

UMIN ID: UMIN000056563

Registered date:06/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 2025/01/06
• Target sample size: 52
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Subjects receive the test foods for 4 weeks
Subjects receive placebo for 4 weeks

Outcome(s)

• Primary Outcome: Fatigue VAS (visual analog scale)
• Secondary Outcome: Endurance performance POMS2 (Profile of Mood States second edition) Sleep-quality questionnaire Blood and urinary metabolites

Key inclusion & exclusion criteria

• Age minimum: 25years-old
• Age maximum: 44years-old
• Gender: Male and Female
• Exclude criteria: 1) Subjects who are unable to refrain from taking health foods, including dietary supplements, or quasi-drugs and over-the-counter drugs that are taken orally that could affect the study. 2) Subjects who habitually take the test food. 3) Subjects who are unable to abstain from smoking. 4) Subjects whose BMI are 25.0 kg/m^2 or more. 5) Subjects who have under treatment or a history of serious disease such as diabetes mellitus, liver disease, renal disease, cardiac disease, circulatory system disease, etc. 6) Subjects who have a disease under treatment or have a pre-existing serious disease that required medication. 7) Subjects who may develop allergic symptoms to the test food or who may develop severe allergic symptoms to the default food to be distributed. 8) Pregnant or planning to become pregnant during the study, and lactating mothers. 9) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies. 10) Subjects who are likely to change their lifestyle, including diet and exercise, during the study. 11) Subjects who fall under the category of menstrual irregularities. 12) Subjects who are judged as unsuitable for the study by principal investigator.

Related Information

• Primary Sponsor: EZAKI GLICO Co., Ltd.
• Source(s) of Monetary Support: None