Effect of food-containing ingredients for motor function. SIC-2024-02-GUTS

UMIN ID: UMIN000054464

Registered date:06/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 2024/07/31
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingredient-containing food. 8 weeks
Ingredient-free food. 8 weeks

Outcome(s)

• Primary Outcome: Index of motor function

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 65years-old
• Gender: Male
• Exclude criteria: 1, Subjects whose systolic blood pressure is less than 90mmHg 2, Subjects in pregnancy or lactation 3, Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks 4, Subjects who are applicable to following items; a, Subjects with disease on heart, liver, kidney or other organs complication. b, Subjects with a previous history of disease on circulatory organs. c, Subjects who are contracting diabetes. d, Subjects with respiratory disease. 5, Subjects who have an unsteady lifestyle because of a working shift or a night shift. 6, Subjects who drink a lot. 7, Smoker except for subjects who quit smoking for more than a year. 8, Subjects whose BMI is less the 18.5 or over 25. 9, Subjects whose systolic pressure >160 mmHg or diastolic pressure >100 mmHg. 10, Subjects who are judged as unsuitable for the study by the result of clinical examination and/or physical examination. 11, Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.

Related Information

• Primary Sponsor: the other
• Source(s) of Monetary Support: Self-funding