Verification study of anti-fatigue effect by ingestion of test beverage

UMIN ID: UMIN000039610

Registered date:09/03/2020

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: N/A(healthy adults)
• Date of first enrollment: 2020/02/21
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake of test beverage for 2 weeks -> Washout for 2 weeks or more -> Intake of placebo beverage for 2 weeks
Intake of placebo beverage for 2 weeks -> Washout for 2 weeks or more -> Intake of test beverage for 2 weeks

Outcome(s)

• Primary Outcome: Fatigue index using questionnaires after 2-week ingestion of test beverage

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 64years-old
• Gender: Female
• Exclude criteria: (1) Subjects who have history of diabetes, liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, peripheral vascular disease, or other serious disease (2) Subjects who are judged by the principal investigator to have abnormal electrocardiogram (3) Subjects who have injuries or illnesses that interfere with ergometer exercise (4) Subjects who are under medical treatment (5) Subjects who are allergic to food and drugs (6) Subjects who cannot avoid taking health foods (including Food for Specified Health Uses, and Foods with Function Claims) and designated quasi-drugs during the test period (7) Subjects who are taking medication (including OTC and prescription drugs) (8) Subjects who have excessive alcohol consumption, or not avoid consumption of alcohol from the day before the test until the end of the test (9) Subjects who are planning to get pregnant after the day of informed consent or are currently pregnant and lactating (10) Subjects who have participated or are planning to participate in other clinical studies during the current study (11) Subjects who are judged ineligible at the discretion of the principal investigator

Related Information

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