NIPH Clinical Trials Search

A study for safety evaluation of 12-weeks consumption of the drink containing indigestible dextrin.

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy adult
Date of first enrollment	2015/07/29
Target sample size	30
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Drink which is contain indigestible dextrin 5g as dietary fiber. Intake 350mL/day, 12 weeks. Drink which is not contain indigestible dextrin. Intake 350mL/day, 12 weeks.

Outcome(s)

Primary Outcome	The incidence of side effects
Secondary Outcome	Blood test Urine test Blood pressure/pulsation Weight/body mass index Medical interview

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	65years-old
Gender	Male and Female
Include criteria
Exclude criteria	(1)Subjects who are given continuous treatment by taking medicines. (2) Subjects who constantly use oral medicines, functional foods and/or supplements having a possibility of affecting test results. (3)Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (4) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (5)Subjects who excessive alcohol intake. (6) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. (7)Subjects who have previous medical history of drug and/or food allergy. (8) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (9)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (10) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. (11) Females who donated over 400mL blood and/or blood components within the last four month to the current study. (12) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (13) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (14)Others who have been determined ineligible by principal investigator or sub-investigator.