Verification test of blood glucose level fluctuation by intake of test food

UMIN ID: UMIN000050450

Registered date:30/06/2023

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: N/A
• Date of first enrollment: 2023/02/06
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Single ingestion of test food-washout period-single ingestion of placebo food.
Single ingestion of placebo food-washout period-single ingestion of test food.

Outcome(s)

• Primary Outcome: Blood glucose levels

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 40years-old
• Gender: Male and Female
• Exclude criteria: 1) Individuals using medical products. 2) Individuals who used a drug for treatment of disease in the past 1 month. 3) Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. 4) Individuals who contract or have a history of serious gastrointestinal disease. 5) Individuals with serious anemia. 6) Individuals who contract or have a history of food allergy. (milk, gelatin) 7) Females who are or are possibly pregnant, or are lactating. 8) Individuals who have an addiction to alcohol or a mental illness. 9) Individuals who are a smoker. 10) Individuals with high blood glucose (fasting blood glucose over 110 mg/dL). 11) Individuals whose life style will change during the test period. 12) Individuals with probable seasonal allergy, such as pollinosis, during the test period.(Betulaceae: alder, oba alnus firma, shirakaba, Taxodiaceae: cryptomeria, hinoki cypress, Asteraceae: ragweed, Artemisia vulgaris indica, Gramineae:Dactylis glomerata, Phleum pratense) 13) )Individuals who had a habit to ingest foods claiming to effect on blood glucose level improvement , foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. 14) Individuals who have a habit to use drug claiming to effect on blood glucose level improvement in the past 3 months. 15) Individuals who conducted hormone replacement therapy in the past 6 months or have a history of conducting hormone replacement therapy. 16) Individuals who were hospitalized and received treatment in the past 6 months, or will be hospitalized during the test period. 17) Individuals who participated in other clinical studies in the past 1 months. 18) Individuals judged inappropriate for the study by the principal.

Related Information

• Primary Sponsor: Morinaga & Co., Ltd.
• Source(s) of Monetary Support: Morinaga & Co., Ltd.