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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05349916
Other study ID # IRB-2021-122
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 7, 2021
Est. completion date March 9, 2022

Study information

Verified date April 2022
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of the current study is to investigate whether consumption of soluble fibers (isomaltodextrin [IMD], partially digestible maltodextrin) and RS4 starch will lower postprandial glycemia as well as postprandial insulin in human subjects with relatively high fasting blood glucose, when consumed with a specific amount of digestible carbohydrate (rice porridge). The primary outcome of the study is the effect of fibers on postprandial blood glucose, whereas the secondary outcome will be its effect on postprandial blood insulin.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 9, 2022
Est. primary completion date March 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 60 Years
Eligibility Inclusion Criteria: - Body mass index (18.5 kg/m² = BMI = 29.9 kg/m²) - No history of abnormal glucose metabolism - No ongoing use of drugs affecting blood glucose levels - Fasting blood glucose between 90-110 mg/dL - Low dietary fiber intake (less than 15 g per day) Exclusion Criteria: - Diabetic individuals - Individuals with history of gastrointestinal disease - Pregnant or nursing women

Study Design


Intervention

Other:
Control
300 g rice porridge + 150 ml drinking water
Isomaltodextrin Low Dose
300 g rice porridge + (5 g IMD in 150 ml drinking water)
Isomaltodextrin High Dose
300 g rice porridge + (10 g IMD in 150 ml drinking water)
GPC partially digestible maltodextrin
300 g rice porridge + (15 g GPC fiber in 150 ml drinking water)
Resistant Starch Type 4
300 g rice porridge + (15 g RS4 starch in 150 ml drinking water)

Locations

Country Name City State
United States Purdue University West Lafayette Indiana

Sponsors (2)

Lead Sponsor Collaborator
Purdue University Grain processing corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postprandial glycemic response Blood glucose will be measured, (AUC) Acute study: [3 hours of measurement after consumption of test food]
Primary Postprandial glycemic response Blood glucose will be measured, (C max) Acute study: [3 hours of measurement after consumption of test food]
Primary Postprandial glycemic response Blood glucose will be measured, (t max) Acute study: [3 hours of measurement after consumption of test food]
Secondary Postprandial insulin response Blood insulin will be measured, (AUC) Acute study: [3 hours of measurement after consumption of test food]
Secondary Postprandial insulin response Blood insulin will be measured, (C max) Acute study: [3 hours of measurement after consumption of test food]
Secondary Postprandial insulin response Blood insulin will be measured, (t max) Acute study: [3 hours of measurement after consumption of test food]
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