NIPH Clinical Trials Search

Safety evaluation of 12 weeks consumption of indigestible dextrin beverage in men and women

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy adult
Date of first enrollment	2015/06/01
Target sample size	33
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	test beverage containing of indigestible dextrin

Outcome(s)

Primary Outcome	Hematologic test Blood biochemistry test Urine analysis Blood pressure/pulsation Weight/ body mass index Doctor's questions Adverse event
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	64years-old
Gender	Male and Female
Include criteria	1) Males and females from 20 to 64 years of age 2) Subjects falling under any of the following A. triglyceride levels are ranged from 120 mg/dL to 199 mg/dL (10 or more subjects) B. blood glucose levels are ranged from 110 mg/dL to 125 mg/dL (10 or more subjects) C. triglyceride levels are less than 120 mg/dL and blood glucose levels are less than 110 mg/dL (10 or more subjects)
Exclude criteria	(1) Subjects having a disease requiring treatment or a history of serious diseases, diabetes, hepatopathy, renal or heart disease (2) Subjects having possibilities for emerging allergy related to the study (3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (5) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (6) Subjects who intend to become pregnant or lactating (7) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (8) Subjects judged as unsuitable for the study by the investigator for other reasons