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

NCT ID: NCT05349916

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2022-03-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postprandial Hyperglycemia Type2 Diabetes Blood Sugar; High

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

300 g rice porridge + 150 ml drinking water

Isomaltodextrin Low Dose

Group Type EXPERIMENTAL

Isomaltodextrin Low Dose

Intervention Type OTHER

300 g rice porridge + (5 g IMD in 150 ml drinking water)

Isomaltodextrin High Dose

Group Type EXPERIMENTAL

Isomaltodextrin High Dose

Intervention Type OTHER

300 g rice porridge + (10 g IMD in 150 ml drinking water)

GPC partially digestible maltodextrin

Group Type EXPERIMENTAL

GPC partially digestible maltodextrin

Intervention Type OTHER

300 g rice porridge + (15 g GPC fiber in 150 ml drinking water)

Resistant Starch Type 4

Group Type EXPERIMENTAL

Resistant Starch Type 4

Intervention Type OTHER

300 g rice porridge + (15 g RS4 starch in 150 ml drinking water)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Control

300 g rice porridge + 150 ml drinking water

Intervention Type OTHER

Isomaltodextrin Low Dose

300 g rice porridge + (5 g IMD in 150 ml drinking water)

Intervention Type OTHER

Isomaltodextrin High Dose

300 g rice porridge + (10 g IMD in 150 ml drinking water)

Intervention Type OTHER

GPC partially digestible maltodextrin

300 g rice porridge + (15 g GPC fiber in 150 ml drinking water)

Intervention Type OTHER

Resistant Starch Type 4

300 g rice porridge + (15 g RS4 starch in 150 ml drinking water)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

22 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Grain processing corporation

UNKNOWN

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bruce R. Hamaker

Distinguished Professor of Food Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-2021-122

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Resistant Starch and Satiety
NCT01187875 COMPLETED EARLY_PHASE1
Satiety Response of Four Dietary Fibers
NCT01233024 COMPLETED EARLY_PHASE1