Verification of the effect of different intake times on the absorption of food components

UMIN ID: UMIN000054045

Registered date:05/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2024/04/08
• Target sample size: 36
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A single ingestion of the test food (200 mL) at breakfast time.
A single ingestion of the test food (200 mL) at lunch time
A single ingestion of the test food (200 mL) at dinner time.

Outcome(s)

• Primary Outcome: Area under the food component concentration curve (AUC) in the serum triglyceride-rich lipoprotein fraction and the change of AUC.
• Secondary Outcome: Concentration of the food component in the serum triglyceride-rich lipoprotein fraction after ingestion of the test food and the change from before ingestion.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 40years-old
• Gender: Male and Female
• Exclude criteria: 1. Whose body mass index (BMI) is less than 18.5 or above 25. 2. Who has a history of major surgery on the digestive system (except appendicitis). 3. Who visit the hospital for treatment of illnesses or receiving medication. 4. Lactating, pregnant or planning to be pregnant during this trial. 5. who have allergic reaction to test foods. 6. Smokers (who have smoked within the last 6 months). 7. Who have irregular lifestyles, such as shift workers and late-night workers. 8. Who consume vegetable or vegetable-fruit drinks on a daily basis (approx. three times a week or more). 9. Who have given blood in the last six months. 10. Who have participated in other human trials within one month. 11. Who are judged unsuitable for this trial by the principal investigator.

Related Information

• Primary Sponsor: KAGOME CO., LTD.
• Secondary Sponsor: CPCC Company Limited
• Source(s) of Monetary Support: None