Effects of a Functional Food for a Subject of the Specific Health Guidance.

UMIN ID: UMIN000047213

Registered date:18/03/2023

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: No
• Date of first enrollment: 2022/04/23
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Oral intake of healthy meals (one time in a day [eating for lunch; 12 weeks] from every Monday to Friday).
Oral intake of normal meals (keeping habit of eating before participating with the study; 12 weeks).

Outcome(s)

• Primary Outcome: Visceral fat area
• Secondary Outcome: *Secondary indexes [1] Waist circumference [2] BMI [3] Blood triglyceride level [4] HDL-cholesterol level [5] Blood pressure [6] Blood glucose level [7] HbA1c [8] Ratio of those who achieved weight loss of 2 kg and abdominal circumference reduced by 2 cm (achievement of specific health guidance goals) [9] Ratio of people who are actively supported by specific health guidance

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 65years-old
• Gender: Female
• Exclude criteria: [1] Individuals who have difficulty in intaking a test food as a weekday lunch for 12 weeks continuously during the study period. [2] Individuals who sometimes misses lunch on weekdays. And individuals who have difficulty intaking a test food as lunch. [3] Individuals who are receiving the Specific Health Guidance. Or individuals who may receive the Specific Health Guidance during the test period. [4] Individuals who are scheduled to undergo a medical examination during the test period. [5] Individuals who are in constipation. [6] Individuals using medical products. [7] Individuals who have a history of or are a patient of mental illness, sleep disorders, diabetes or serious illness. [8] Individuals with metal in their body that cannot be removed. Individuals with a cardiac pacemaker. [9] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [10] Individuals who contract or have a history of serious endocrine disease. [11] Individuals who recorded weight gain and loss (+-2 kg) in the past 1 month. [12] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [13] Individuals who are sensitive to test product or other foods, and medical products. [14] Individuals who excessively take alcohol. [15] Individuals who have and have had within the past three months the habit of continuously intaking foods for food for Specified Health Uses, Foods with Functional Claims, and health foods that claim to reduce lipid metabolism, glucose metabolism, blood pressure, visceral fat and body fat, and who plan to intake these foods during the test period. [16] Individuals who are or are possibly pregnant, or are lactating. [17] Individuals who participated in other clinical studies in the past 3 months. [18] Individuals who are or whose family is engaged in health foods of functional foods. [19] Individuals judged inappropriate for the study by the principal.

Related Information

• Primary Sponsor: TES Holdings Co., Ltd.
• Source(s) of Monetary Support: Non-disclosure