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

• Sponsor: Purdue University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05349916
• Collaborator: Grain processing corporation (Other)
• Enrollment: 24
• Location: 1
• Arms: 5
• Actual Duration (Months): 3
• Patients Per Site Per Month: 7.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postprandial Hyperglycemia; Type2 Diabetes; Blood Sugar; High	Other: Control; Other: Isomaltodextrin Low Dose; Other: Isomaltodextrin High Dose; Other: GPC partially digestible maltodextrin; Other: Resistant Starch Type 4	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: The Attenuating Effect of Soluble Fiber Consumption on Postprandial Glycemia in Humans
• Actual Study Start Date: Dec 7, 2021
• Actual Primary Completion Date: Mar 9, 2022
• Actual Study Completion Date: Mar 9, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Postprandial glycemic response [Acute study: [3 hours of measurement after consumption of test food]]

   Blood glucose will be measured, (AUC)

2. Postprandial glycemic response [Acute study: [3 hours of measurement after consumption of test food]]

   Blood glucose will be measured, (C max)

3. Postprandial glycemic response [Acute study: [3 hours of measurement after consumption of test food]]

   Blood glucose will be measured, (t max)

Secondary Outcome Measures

1. Postprandial insulin response [Acute study: [3 hours of measurement after consumption of test food]]

   Blood insulin will be measured, (AUC)

2. Postprandial insulin response [Acute study: [3 hours of measurement after consumption of test food]]

   Blood insulin will be measured, (C max)

3. Postprandial insulin response [Acute study: [3 hours of measurement after consumption of test food]]

   Blood insulin will be measured, (t max)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Purdue University	West Lafayette	Indiana	United States	47907

Sponsors and Collaborators

• Purdue University
• Grain processing corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bruce R. Hamaker, Distinguished Professor of Food Science, Purdue University
• ClinicalTrials.gov Identifier: NCT05349916
• Other Study ID Numbers: IRB-2021-122
• First Posted: Apr 27, 2022
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperglycemia

Study Results

No Results Posted as of Apr 27, 2022