The Attenuating Effect of Soluble Fiber Consumption on Postprandial Glycemia in Humans

Type2 Diabetes Clinical Trial

Official title:

The Attenuating Effect of Soluble Fiber Consumption on Postprandial Glycemia in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349916
• Other study ID #: IRB-2021-122
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Blood Sugar; High
• Hyperglycemia
• Postprandial Hyperglycemia
• Type2 Diabetes

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]