Healthy subjects
Conditions
Interventions
Intake of active food-Washout period-Intake of placebo food
Intake of placebo food-Washout period-Intake of active food
Sponsors
others
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese men and women between 30 and 65 years of age at the time of obtaining written informed consent. 2.Subjects who are not in the habit of exercising (not meeting the following definition) *Subjects who have been exercising at least twice a week for at least 30 minutes each time for one year. 3.Subjects who have been fully explained the purpose and contents of the study ,are capable of consenting, fully understand the content ,and voluntarily volunteer to participate in the study and agree to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1.Subjects who are taking medication or under medical treatment. 2.Subjects who are under exercise therapy or dietetic therapy. 3.Subjects who have developed allergies as for the foods test. 4.Subjects with current or history of drug dependence or alcohol dependence. 5.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past. 6.Subjects with smoking habit.(Have smoked within the last year.) 7.Subjects with irregular life rhythms due to night shifts or shift work. 8.Subjects with heavy alcohol consumption.(Subjects whose average daily net alcohol intake exceeds approximately 60g) 9.Subjects with extremely irregular lifestyle habits such as eating and sleeping. 10.Subjects who have an extremely unbalanced diet. 11.Subjects with serious current or previous illnesses such as brain disease, malignancy, immunological disease, diabetes, liver disease (hepatitis),renal disease, cardiac disease, thyroid disease, adrenal gland disease, tendon disease, joint contracture, orthopedic disease, or other metabolic diseases. 12.Subjects who have suffered a serious injury to the locomotor organs such as fracture, tendon rupture, or flesh tear within the past year, or who have difficulty performing exercise load due to pain or discomfort in the locomotor organs. 13.Subjects using health foods, supplements, and medications that reduce fatigue. 14.Subjects who have participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period. 15.Subjects who have collected 200mL of blood or donated more than 400mL of blood within 3months from the date of consent acquisition. 16.Subjects who are planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue of visual analogue scale | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Autonomic Nervous System (LF/HF),CK,lactic acid,High sensitivity IL-6,d-ROMs (Safety evaluation) Vital signs,body measurements(weight,BMI),blood biochemistry,hematology,Urinalysis,adverse events | — |
Countries
Japan
Contacts
Public ContactMasao Matsuoka
MIS Co., Ltd. Clinical Development Department
Outcome results
None listed