NIPH Clinical Trials Search

A study for evaluating the effect of the intake of an indigestible dextrin-containing carbonated drink on postprandial hyperglycemia : randomized, placebo-controlled, double blind cross-over trial

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy adult
Date of first enrollment	2016/03/05
Target sample size	62
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	test carbonated drink with indigestible dextrin (single ingestion) - washout period - placebo carbonated drink without indigestible dextrin (single ingestion) placebo carbonated drink without indigestible dextrin (single ingestion) - washout period - test carbonated drink with indigestible dextrin (single ingestion)

Outcome(s)

Primary Outcome	area under the curve of plasma glucose
Secondary Outcome	Postprandial blood glucose, maximum plasma glucose level, insulin

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	64years-old
Gender	Male and Female
Include criteria
Exclude criteria	(1) Subjects who routinely use food containing of indigestible dextrin (2) Subjects routinely taking medicine or health food which may influence glucose metabolism (3) Subjects who are under medication or having a history of serious diseases for which medication was required (4) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (5) Subjects having possibilities for emerging allergy related to the study (6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (7) 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 (8) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (10) Subjects judged as unsuitable for the study by the investigator for other reasons