Study of the effects of food ingredient intake on body fat. (SBD-2024-02-RHKLU)

UMIN ID: UMIN000054579

Registered date:10/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 2024/06/11
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Daily intake of test food for 16 weeks.
Daily intake of control food for 16 weeks.

Outcome(s)

• Primary Outcome: Abdominal visceral fat area
• Secondary Outcome: Abdominal total fat area, Abdominal subcutaneous fat area, Body weight, BMI, Waist circumferences

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: (1) Those with systolic blood pressure less than 90 mmHg. (2) Women who wish to become pregnant, are/might be pregnant or lactating during the study. (3) Those who are participating in other study or planning to participate or participated within the past 4 weeks. (4) Those who are: a) heart, liver, or kidney disease (including complications of other diseases) b) having a history of cardiovascular disease c) diabetes d) allergic to test foods e) having a respiratory illness (5) Those who are receiving any treatment at the time of screening. (6) Those who continuously take medicines. (7) Those who continuously ingest foods for specified health use, foods with functional claims, health foods, and foods that may affect body fat evaluation. (8) Those who heavy use of alcohol or smoke. (9) Those who have regular hard exercise. (10) Others who are judged inappropriate for participant by the investigator.

Related Information

• Primary Sponsor: Suntory Holdings Limited
• Source(s) of Monetary Support: None