NIPH Clinical Trials Search

Investigation of the effectiveness of resistant maltodextrin intake for 24 weeks on glycometabolism

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Male and female who are aged 20 years and older and who have high HbA1c levels
Date of first enrollment	2016/09/13
Target sample size	30
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Intake 2 packages of resistant maltodextrin a day for 24 weeks Intake 2 packages of dextrin a day for 24 weeks

Outcome(s)

Primary Outcome	(1)Efficacy: HbA1c (2)Safety: The incidence of side effects
Secondary Outcome	(1)Efficacy: OGTT, GA, 1.5-AG, GLP-1, intestinal flora (2)Safety: The incidence of adverse events

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	(1) Subjects who are diagnosed as diabetes and receiving treatment. (2) Subjects who constantly take oral medicines, functional foods and/or supplements that have a possibility to affect the test results. (3) Females who are pregnant or lactating, and females who have possibility of pregnancy. (4) Subjects who donated blood and/or blood components more than 200 mL within 4 weeks prior to the test. (5) Males who donated blood and/or blood components more than 400 ml within 12 weeks prior to the test. (6) Females who donated blood and/or blood components more than 400 ml within 16 weeks prior to the test. (7) Males who were collected blood and blood components more than 1200 ml within 12 months prior to the test when planned blood sampling amount of this test is added. (8) Females who were collected blood and blood components more than 800 ml within 12 months prior to the test when planned blood sampling amount of this test is added. (9) Subjects who are participating in other clinical tests, and/or subjects who participated in other clinical tests within 4 weeks prior to the test. (10) Subjects who consume excessive amount of alcohol or smoke heavily (more than 21 cigarettes a day). (11) Subjects who have extremely irregular dining habits, and/or subjects who work midnight or irregular shifts. (12) Subjects who falls under any of the following criteria. (a) Subjects who have heart disease, liver disease, or kidney disease (including the complication of other diseases). (b) Subjects who have medical history of cardiovascular diseases. (c) Subjects who are allergic to the test foods. (13) Subjects who are judged as unsuitable for this study by principal investigator or sub-investigator.