Healthy volunteers
Conditions
Interventions
None listed
Sponsors
Maruzen Pharmaceuticals Co., LTD.
Professor Hiroharu Kamioka, Tokyo University of Agriculture
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants: Healthy volunteers Intervention: Intake of food containing astaxanthin (dietary intake: 5~40 mg, period: 2~12 weeks) Comparison: Intake of placebo food Outcome: Primary; Autonomic nerve functions Key secondary; VAS (fatigue) Study design: Randomized, double-blind, placebo-controlled parallel group trial or randomized, double-blinded cross-over trial Literature targeting human clinical trials. The keywords used in the literature search will be in English or Japanese only.
Exclusion criteria
Exclusion criteria: Literature which does not match with PICOS will be excluded. Participants who are suffering from illness, planning or currently pregnant or breastfeeding, children (persons under 18 years), and those suffering chronic fatigue syndrome will be excluded from this study. Studies with subjects aged 18 or 19 may be subject to inclusion in the study if the number of such subjects is less than half of the total number of adults included in the study, and if approval of the Ethics Review Committee is gained. Foods which have special dosage forms or go through special digestion/ absorption pathway will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Autonomic nerve functions The outcomes are taken from guideline issued by the Japanese Society of Fatigue Science. | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS (fatigue) | — |
Countries
Japan
Contacts
Public ContactMika Minamida
Maruzen Pharmaceuticals Co., Ltd. Research & Development div.
Outcome results
None listed