A study on the effect of powdered tea on postprandial hyperglycemia- A randomized, double-blind, placebo-controlled, cross-over trial

Not Applicable

Completed

• Conditions: Healthy adult (subjects with impaired fasting glucose (fasting plasma glucose = 110-125 mg/dl) or impaired glucose tolerance (75g-OGTT 2 hour glucose = 140 - 199 mg/dl))

• Registration Number: JPRN-UMIN000020763
• Lead Sponsor: KSO Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) Males and females from 20 to 64 years age
2) Subjects whose fasting plasma glucose levels are from 110 to 125 mg/dl or whose 75g-oral glucose tolerance test (OGTT) 2 hour glucose levels are from 140 to 199 mg/dl
3) Not heavy alcoholic drinker. (Subjects who can stop drinking from 2 days before each measurement.)
4) Subjects who can make self-judgment and are voluntarily giving written informed consent

Exclusion Criteria

1) Subjects who use oral medication affecting blood glucose
2) Subjects who constantly consume supplements and/or functional foods (including Food for Specified Health Uses) affecting blood glucose
3) Subjects who have declared allergic reaction to ingredients contained in powdered tea, placebo or high-carbohydrate diet
4) Subjects who need medical treatment for diabetes
5) Subjects who contract or are under treatment or are medical history for serious diseases (e.g., liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder
6) Subjects who have a chronic disease and use medicines continuously
7) Subjects who have a history of digestive disease affecting digestion and absorption
8) Subjects whose blood glucose level measured by simple analyzer is more than 150 mg/dl
9) Subjects who are judged as unsuitable for the study based on the results of blood tests by the investigator
10) Subjects who have donated over 200 ml of blood and/or blood components within the last one month prior to the current study or over 400 ml of blood and/or blood components within the last three months prior to the current study
11) Subjects who are diagnosed as anemic and not suitable for frequent collection of blood
12) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism
13) Subjects who are planning to participate in other clinical studies
14) Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating
15) Subjects who are judged as unsuitable for the study by the investigator for other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified