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

Primary Purpose

Postprandial Hyperglycemia, Type2 Diabetes, Blood Sugar; High

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Isomaltodextrin Low Dose
Isomaltodextrin High Dose
GPC partially digestible maltodextrin
Resistant Starch Type 4
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postprandial Hyperglycemia

Eligibility Criteria

22 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Isomaltodextrin Low Dose

Isomaltodextrin High Dose

GPC partially digestible maltodextrin

Resistant Starch Type 4

Arm Description

Outcomes

Primary Outcome Measures

Postprandial glycemic response
Blood glucose will be measured, (AUC)
Postprandial glycemic response
Blood glucose will be measured, (C max)
Postprandial glycemic response
Blood glucose will be measured, (t max)

Secondary Outcome Measures

Postprandial insulin response
Blood insulin will be measured, (AUC)
Postprandial insulin response
Blood insulin will be measured, (C max)
Postprandial insulin response
Blood insulin will be measured, (t max)

Full Information

First Posted
October 17, 2021
Last Updated
April 22, 2022
Sponsor
Purdue University
Collaborators
Grain processing corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05349916
Brief Title
The Attenuating Effect of Soluble Fiber Consumption on Postprandial Glycemia in Humans
Official Title
The Attenuating Effect of Soluble Fiber Consumption on Postprandial Glycemia in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
March 9, 2022 (Actual)
Study Completion Date
March 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Grain processing corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia, Type2 Diabetes, Blood Sugar; High

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Title
Isomaltodextrin Low Dose
Arm Type
Experimental
Arm Title
Isomaltodextrin High Dose
Arm Type
Experimental
Arm Title
GPC partially digestible maltodextrin
Arm Type
Experimental
Arm Title
Resistant Starch Type 4
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
300 g rice porridge + 150 ml drinking water
Intervention Type
Other
Intervention Name(s)
Isomaltodextrin Low Dose
Intervention Description
300 g rice porridge + (5 g IMD in 150 ml drinking water)
Intervention Type
Other
Intervention Name(s)
Isomaltodextrin High Dose
Intervention Description
300 g rice porridge + (10 g IMD in 150 ml drinking water)
Intervention Type
Other
Intervention Name(s)
GPC partially digestible maltodextrin
Intervention Description
300 g rice porridge + (15 g GPC fiber in 150 ml drinking water)
Intervention Type
Other
Intervention Name(s)
Resistant Starch Type 4
Intervention Description
300 g rice porridge + (15 g RS4 starch in 150 ml drinking water)
Primary Outcome Measure Information:
Title
Postprandial glycemic response
Description
Blood glucose will be measured, (AUC)
Time Frame
Acute study: [3 hours of measurement after consumption of test food]
Title
Postprandial glycemic response
Description
Blood glucose will be measured, (C max)
Time Frame
Acute study: [3 hours of measurement after consumption of test food]
Title
Postprandial glycemic response
Description
Blood glucose will be measured, (t max)
Time Frame
Acute study: [3 hours of measurement after consumption of test food]
Secondary Outcome Measure Information:
Title
Postprandial insulin response
Description
Blood insulin will be measured, (AUC)
Time Frame
Acute study: [3 hours of measurement after consumption of test food]
Title
Postprandial insulin response
Description
Blood insulin will be measured, (C max)
Time Frame
Acute study: [3 hours of measurement after consumption of test food]
Title
Postprandial insulin response
Description
Blood insulin will be measured, (t max)
Time Frame
Acute study: [3 hours of measurement after consumption of test food]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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