Effects of intake of test foods on fatigue and malaise

Not Applicable

• Conditions: Healthy Japanese subjects

• Registration Number: JPRN-UMIN000050377
• Lead Sponsor: APO PLUS STATION CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-17
• Study Completion: 2023-09-29
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Persons who suffer from or have a history of serious heart disease, lung disease, gastrointestinal disease (esophagus, stomach, small intestine, large intestine, liver, kidney, etc.), hypertension, diabetes, malignant tumor, etc. (2) Persons with food allergies or who may be allergic to the test food. (3) Persons who regularly use licensed drugs or quasi-drugs that may affect the study. (4) Persons who regularly use health foods (food for specified health uses, food with nutrient function claims, food with functional claims, supplements, etc.) that may affect the study. (5) Persons who may be unable to discontinue the current drugs intake of pharmaceutical (excluding drugs used as needed), quasi-drugs, or health foods (food for specified health uses, food with nutrient function claims, food with functional claims, supplements, etc.) from the time of obtaining consent to the completion of the study. (6) Persons who on work day and night shifts and those who are scheduled to work on night shift during the period of the study. (7) Persons who are attending hospital for mental disorders (depression, etc.) or sleep disorders, or have a history of mental illness in the past. (8) Persons whose drink more than 100 g of alcohol equivalent per week. (9) Persons who drink alcohol more than 5 days per week. (10) Persons who smoke more than 20 cigarettes per day. (11) Persons who are participating in a clinical trial or have participated in another clinical trial within 3 months from the date of obtaining consent. (12) Persons who plan to participate in other examinations during the study. (13) Persons who may be unable to maintain their daily lifestyle (diet, exercise, alcohol consumption, smoking, etc.). (14) Persons who have difficulty in intaking study food as directed. (15) Persons who ones pregnant or breast feeding or planning to become pregnant during the study. (16) Persons who are deemed inappropriate for this study by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified