Examination of fatigue feeling-reducing effects by test-food intakes (a preliminary study)

UMIN ID: UMIN000050794

Registered date:14/04/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy male/female adults
• Date of first enrollment: 2023/04/14
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingestion of the test beverage (150 g) to the subject, one bottle a day.
Ingestion of the placebo beverage (150 g) to the subject, one bottle a day.

Outcome(s)

• Primary Outcome: Subjective questionnaires: Visual Analogue Scale (a general/physical/psychological fatigue feeling, The Profile of Mood States Second Edition (Japanese short ver.)
• Secondary Outcome: 1. Acceleration of pulse waveform 2. Antioxidant activity tests (Diacron-reactive oxygen metabolites/biological antioxidant potential/malondialdehyde (thiobarbituric acid-reactive substances) in blood, and 8-hydroxy-2'-deoxyguanosine/15-isoprostane in urine) 3. Saliva examination (cortisol and chromogranin)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: (1) Subjects who take steadily (not less than three times a week) in the health-specific/functional (e.g., gamma-aminobutyric acid, imidazole dipeptide, reduced coenzyme Q10, L-theanine, citric acid)/supplementary/health foods, which might affect the test results. (2) Subjects who have taken affecting medicines (e.g., Alinamin-A, Chocola-BB), and have any difficulty in refraining from taking them during this study. (3) Subjects who take excessive alcohol. (4) Subjects who are now under another clinical test with some kind of medicine/food, or participated in that within four weeks before this study, or are planning to join that after the consent. (5) Subjects having a physical labor, or getting excessive exercise every day. (6) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney and/or digestive organs. (7) Pregnant, lactating women, and possibly pregnant ones. (8) Subjects having drug and/or food allergy. (9) Subjects who donated over 200 mL of their blood and/or blood components within a month to this study. (10) Males who donated their whole blood (400 mL) within the last three months to this study. (11) Females who donated their whole blood (400 mL) within the last four months to this study. (12) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this study. (13) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this study. (14) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.

Related Information

• Primary Sponsor: CPCC Company Limited
• Source(s) of Monetary Support: ASAHI SOFT DRINKS CO., LTD.