A pilot study to confirm the effects of test foods on fatigue

UMIN ID: UMIN000056568

Registered date:11/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healty volunteers
• Date of first enrollment: 2025/01/11
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Oral intake of test food for 8 weeks

Outcome(s)

• Primary Outcome: Heart rate variability (HRV) after exercise
• Secondary Outcome: Pulse score after exercise load Body composition index Fatigue VAS

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1) Those who have been taking medicines regularly within the last 3 months prior to the start of the study (excluding temporary medications such as painkillers and cold medicines) 2) Those with serious illnesses (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental illnesses 3) Those with a history of serious illness (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or digestive system disease 4) Those who have taken specific health foods, functional foods, health foods (including supplements), etc., more than three times a week within the three months prior to the start of the study, which may affect the study 5) Those who cannot stop taking foods for specified health uses, foods with functional claims, health foods (including supplements), etc. that may affect the study during the study period. 6) Those who are pregnant or breastfeeding, or who plan to or wish to do so during the study period 7) Those who drink a lot of alcohol (40g or more of pure alcohol per day on average) 8) Those with extremely irregular eating habits or those with irregular lifestyles such as working night shifts 9) Those with drug or food allergies 10) Those who have participated in a clinical trial regarding fatigue within 6 months of the start of the study 11)Those who are currently participating in a clinical trial of another drug or health food, have completed the trial within 4 weeks, or are scheduled to participate in another clinical trial while participating in this study. 12)Those who are deemed ineligible to participate in this study by the investigator

Related Information

• Primary Sponsor: MITSUBISHI GAS CHEMICAL COMPANY, INC.
• Source(s) of Monetary Support: MITSUBISHI GAS CHEMICAL COMPANY, INC.