Verification study on the effect of the test foods on physical fitness.

UMIN ID: UMIN000051522

Registered date:04/07/2023

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 2023/07/05
• Target sample size: 166
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Daily intake of test food for 12 weeks
Daily intake of placebo (control food) for 12 weeks

Outcome(s)

• Primary Outcome: 6-min walk test
• Secondary Outcome: Grasping power Sit-ups Anteflexion Repetitive side jump Standing broad jump Step workout 10-m walk test Vertical jump d-ROMs BAP Simple OSP (urinary 8-OHdG/creatinine corrected, PAO) Oxidized LDL

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude criteria: 1.Those who suffer from or have a history or present condition of liver disease, kidney disease, cerebrovascular disease, diabetes, dyslipidemia, hypertension or other chronic diseases. 2.Those who are on treatment for a serious illness. 3.Those who have found ischemia or arrhythmia in a medical examination, etc., and have been pointed out. 4.Those who have a history of orthopedic surgery such as hips and knees that interfere with movement. 5.Those who have difficulty in exercising due to back pain, knee pain, etc. 6.Those who are prohibited from exercising by a physician. 7.Those with SBP greater than 160 mmHg or DBP greater than 100 mmHg at screening test. 8.Those with food allergies or those who may be allergic to the test food. 9.Those who regularly use licensed drugs or quasi-drugs that may affect the study. 10.Those who regularly use health foods that may affect the study. 11.Those who are participating in a clinical trial or have participated in another clinical trial within 1 months from the date of obtaining consent. 12.Those who are habitual smokers or who smoked within one year before the start of the study. 13.Those who have irregular daily life. 14.Those who may be unable to maintain their daily lifestyle. 15.Those who are pregnant or breastfeeding or planning to become pregnant during the study. 16.Those who plan to participate in any other clinical trial during the study. 17.Those who are being treated or have a history of malignant tumors, heart failure, or myocardial infarction. 18.Those who have implanted pacemakers or implantable cardioverter defibrillators. 19.Those who have a habit of regular exercise. 20.Those who may take unscheduled exercise or plan to start exercise by this December. 21.Those who are professional athletes. 22.Those who are undergoing treatment for chronic diseases. 23.Those who regularly drink exceeding 20 g of alcohol equivalent per day. 24.Those who are deemed inappropriate for this study by the investigator.

Related Information

• Primary Sponsor: Other
• Source(s) of Monetary Support: Other