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Completed

NCT Number: NCT05349916

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.

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Key information

Conditions

Postprandial Hyperglycemia Blood Sugar; High Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Type2 Diabetes

Age range

22 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

300 g rice porridge + 150 ml drinking water

Isomaltodextrin Low Dose

Other

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

Isomaltodextrin High Dose

Other

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

GPC partially digestible maltodextrin

Other

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

Resistant Starch Type 4

Other

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

Primary outcomes

  1. Postprandial glycemic response

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

    Blood glucose will be measured, (AUC)

  2. Postprandial glycemic response

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

    Blood glucose will be measured, (C max)

  3. Postprandial glycemic response

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

    Blood glucose will be measured, (t max)

Secondary outcomes

  1. Postprandial insulin response

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

    Blood insulin will be measured, (AUC)

  2. Postprandial insulin response

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

    Blood insulin will be measured, (C max)

  3. Postprandial insulin response

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

    Blood insulin will be measured, (t max)

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Grain processing corporation

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2022
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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