NIPH Clinical Trials Search

A clinical study for evaluating the efficacy of soft drink containing reduced type of indigestible dextrin on the suppression of the elevation of postprandial serum triglyceride. -Randomised double-blind placebo-controlled trial

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy adult
Date of first enrollment	2016/04/23
Target sample size	90
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Soft drink containing reduced type of indigestible dextrin (1 day) Soft drink not containing reduced type of indigestible dextrin (1 day)

Outcome(s)

Primary Outcome	Time course of serum triglyceride level and AUC (area under the curve)(0-6hrs)
Secondary Outcome	Time course of serum RLP-cholesterol level and AUC (area under the curve)(0-6hrs). Time course of serum level in total cholesterol, HDL cholesterol, LDL cholesterol, phospholipids, free fatty acids, beta-lipoprotein, glucose and insulin(0-6hrs)

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	65years-old
Gender	Male and Female
Include criteria
Exclude criteria	(1) Individuals who use oral medication affecting lipid metabolism (2) Individuals who constantly use supplements and/or functional foods, including food for specified health use and/or food with function claims, affecting lipid metabolism (3) Individuals whose IBM is less than 18 or 30 and over at the screening checkup (4) Individuals who can't stop drinking for 2 days until the screening checkup (5) Individuals who declare the allergy symptoms against high-fat diets (6) Individuals who are suffered from or under treatment of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder (7) Individuals who have a chronic disease and use medicines continuously (8) Individuals who have a history of digestive disease and/or surgical history affecting digestion and absorption (9) Individuals who are judged as unsuitable for the study based on the results of blood test (10) Individuals who have donated over 200 mL of blood and/or blood component within the last one month prior to the current study or over 400 mL of blood and/or blood component within the last three months prior to the current study. (11) Individuals who are diagnosed as familial hyperlipidemia (12) Individuals who are diagnosed as severe anemia and not suitable for frequent collection of blood (13) Individuals who are under treatment or have a history of drug/alcohol dependence (14) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics (15) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (16) Individuals who are judged as unsuitable for the study by the investigator for the other reasons