NCT05349916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 7, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

October 17, 2021

Last Update Submit

April 22, 2022

Conditions

Postprandial HyperglycemiaType2 DiabetesBlood Sugar; High

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Postprandial insulin response

    Acute study: [3 hours of measurement after consumption of test food]

  • Postprandial insulin response

    Acute study: [3 hours of measurement after consumption of test food]

  • Postprandial insulin response

    Acute study: [3 hours of measurement after consumption of test food]

Study Arms (5)

Control

EXPERIMENTAL
Other: Control

Isomaltodextrin Low Dose

EXPERIMENTAL
Other: Isomaltodextrin Low Dose

Isomaltodextrin High Dose

EXPERIMENTAL
Other: Isomaltodextrin High Dose

GPC partially digestible maltodextrin

EXPERIMENTAL
Other: GPC partially digestible maltodextrin

Resistant Starch Type 4

EXPERIMENTAL
Other: Resistant Starch Type 4

Interventions

ControlOTHER

300 g rice porridge + 150 ml drinking water

Control
Isomaltodextrin Low DoseOTHER

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

Isomaltodextrin Low Dose
Isomaltodextrin High DoseOTHER

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

Isomaltodextrin High Dose
GPC partially digestible maltodextrinOTHER

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

GPC partially digestible maltodextrin
Resistant Starch Type 4OTHER

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

Resistant Starch Type 4

Eligibility Criteria

Age22 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Diabetic individuals
  • Individuals with history of gastrointestinal disease
  • Pregnant or nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

isomaltodextrin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor of Food Science

Study Record Dates

First Submitted

October 17, 2021

First Posted

April 27, 2022

Study Start

December 7, 2021

Primary Completion

March 9, 2022

Study Completion

March 9, 2022

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)