Study on bioavailability of newly developed saccharide material, 1-deoxymannose, in humans

UMIN ID: UMIN000054040

Registered date:02/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2024/04/10
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: 1 day Test materials: 1-deoxymannose Dose: 5 g Administration: Take once a day at once with water
Duration: 1 day Test materials: 1-deoxymannose Dose: 2.5 g Administration: Take once a day at once with water
Duration: 1 day Test materials: 1-deoxymannose Dose: 1 g Administration: Take once a day at once with water
Duration: 1 day Test materials: fructooligosaccharide Dose: 5 g Administration: Take once a day at once with water
Duration: 1 day Test materials: mannose Dose: 5 g Administration: Take once a day at once with water

Outcome(s)

• Primary Outcome: Analysis of exhaled hydrogen gas
• Secondary Outcome: Urinary excretion amount of 1-deoxymannose

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 30years-old
• Gender: Male and Female
• Exclude criteria: The exclusion criteria are diabetes mellitus, abnormal glucose metabolism, respiratory disease, chronic gastrointestinal disease (inflammatory bowel disease, irritable bowel syndrome, functional dyspepsia, etc.), abdominal surgery, history of abnormal bowel movements, blood disorders, food allergies, or BMI of 25.0 or higher. Smokers, excessive alcohol drinkers, and pregnant or lactating women will be excluded. Also exclusion criteria are those who regularly consume non-digestible and absorbable carbohydrates, including dietary fiber, and those who routinely consume pharmaceuticals, foods for specified health uses, functional foods, or health foods.

Related Information

• Primary Sponsor: Nakamura Gakuen University
• Secondary Sponsor: Jumonji University
• Source(s) of Monetary Support: Other,SUNUS Co., Ltd.