Healthy volunteers
Conditions
Interventions
Subjects receive 3 tablets/day containing a total of 30 mg of 5-aminolevulinic acid phosphate and 34.5 mg of sodium ferrous citrate (3.6 mg as Fe) for 2 weeks.
Subjects receive 3 placebo tablets/day
Sponsors
Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy with physical fatigue on a day-to-day basis
Exclusion criteria
Exclusion criteria: 1) Taking medicines for chronic disease 2) Taking medicines or functional food that may affect the trial 3) Participation in any clinical trial within 90 days of the commencement of the trial 4) In pregnancy or nursing a child 5) History of severe disease and/or major surgery 6) Judged as ineligible by clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of VAS (Visual Analogue Scale) for physical fatigue (Time frame: Baseline and every day during each administration period) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline of salivary IgA and cortisol (Time frame: Baseline and day 5, 6, 12, and 13 during each administration period) | — |
Countries
Japan
Contacts
Public ContactFumiko Higashikawa
Hiroshima University, Institute of Biomedical & Health Sciences Project Research Center for Clinical Trial and Preventive Medicine
Outcome results
None listed