Healthy subjects
Conditions
Interventions
Continuous intake of the test foods for 8 weeks.
Continuous intake of the placebo foods for 8 weeks.
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese male and female who are between 20 and less than 60 years old at the time of obtaining written consent. 2.POMS2 All Items Version VA T score : <= 50 3.Subject who feels fatigue on a daily basis. 4.Subject who feels slight drowsiness during the day. 5.Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing.
Exclusion criteria
Exclusion criteria: 1.Subject who is considered as chronic fatigue syndrome or idiopathic chronic fatigue by a doctor and has severe malaise. 2.Subject who is taking medication or under medical treatment due to serious illness. 3.Subject who is under exercise therapy or dietetic therapy. 4.Subject who has not taken foods containing active ingredients or do not like to take them. 5.Subject who has a weak stomach or has tendency to get diarrhea by consuming foods containing active ingredients. 6.Subject who has or had a history of either medicine or alcohol dependence syndrome. 7.Subject who is attending a hospital due to mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea syndrome, etc.), or who has a history of mental illness in the past. 8.Subject with irregular life rhythms due to night shifts or shift work. 9.Subject with extremely irregular lifestyle habits such as eating and sleeping. 10.Subject who has an extremely unbalanced diet. 11.Subject who is alcohol drinking habit (more than 60g/day) 12.Excessive smokers (more than 20 cigarettes/day) 13.Subject with BMI <17kg/m2 or >=30kg/m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indexes to evalute vitality and energy (POMS2 All Items Version, Visual Analog Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Performance-related indices, Daytime sleepiness scale, Objective sleep status, Physical activity level (Safety evaluation) Vital signs, physical measurements (weight, BMI),adverse events | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed