MedPath

The attenuating effect of HBF2020-02 on postprandial blood glucose levels in healthy human subjects -A placebo controlled, randomized, double blind, cross-over study

Not Applicable
Conditions
/A (healthy adults)
Registration Number
JPRN-UMIN000042161
Lead Sponsor
KSO Corporation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

[1] Who use medical products affecting blood glucose. [2] Who can't stop using supplements and/or functional foods including "foods for specified health use" and/or "food with function claims" which affecting blood glucose level during the study period. [3] Who can't abstinent from alcohol from two days before each examination. [4] Who are allergic to placebo food and/or test food and/or the ingredient of high-carbohydrate diet. [5] Who are judged to be diagnosed with diabetes or carbohydrate metabolic disorders. [6] Who have a history of serious kidney damage, hepatopathy, heart disease, respiratory disease, endocrine disease, or any other metabolic disease(s) or who is under medical treatment. [7] Who have chronic disease and is under medication. [8] Who have digestive organ disease, surgical history affecting digestion and absorption of foods, or a disorder such as stenosis in the digestive tract. [9] Who are judged inappropriate for the study by the investigator. [10] Who are diagnosed as severe anemia in screening and not suitable for frequent collection of blood. [11] Who had an onset diarrhea within a week from the date of screening, and/or who are prone to diarrhea on a daily basis. [12] Who donated blood over 200mL in the past a month or over 400mL in the past 3 months from the date of informed consent. [13] Drug addict and/or alcohol addict. [14] Who are participating in other studies that using food(s), pharmaceutical(s), and cosmetic(s) now, or who have participated or are willing to participate in other studies within a month from the date of informed consent. [15] Who are or are possibly pregnant, or who are lactating, during the study period. [16] Who are judged inappropriate for the study by the investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath