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

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes; Postprandial Hyperglycemia; Blood Sugar; High
• Intervention / Treatment: Other: Control; Other: Isomaltodextrin Low Dose; Other: Isomaltodextrin High Dose; Other: GPC partially digestible maltodextrin; Other: Resistant Starch Type 4

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47907
      • Purdue University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial glycemic response	Blood glucose will be measured, (AUC)	Acute study: [3 hours of measurement after consumption of test food]
Postprandial glycemic response	Blood glucose will be measured, (C max)	Acute study: [3 hours of measurement after consumption of test food]
Postprandial glycemic response	Blood glucose will be measured, (t max)	Acute study: [3 hours of measurement after consumption of test food]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial insulin response	Blood insulin will be measured, (AUC)	Acute study: [3 hours of measurement after consumption of test food]
Postprandial insulin response	Blood insulin will be measured, (C max)	Acute study: [3 hours of measurement after consumption of test food]
Postprandial insulin response	Blood insulin will be measured, (t max)	Acute study: [3 hours of measurement after consumption of test food]

Collaborators and Investigators

• Sponsor: Purdue University
• Collaborators: Grain processing corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 7, 2021
• Primary Completion (ACTUAL): March 9, 2022
• Study Completion (ACTUAL): March 9, 2022

Study Registration Dates

• First Submitted: October 17, 2021
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (ACTUAL): April 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: IRB-2021-122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No