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OpenTrials
Completed

NCT Number: NCT06048978

Blood Glucose Response of Processed Starch

The goal of this clinical trial is to determine the postprandial glycemic response of the two starches in humans. Participants will be asked to consume 2 test foods on 2 separate occasions and provide blood glucose samples over 120 minutes postprandial.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INQUIS Clinical Research Ltd.

Toronto, Ontario, M5C 2N8, Canada

About this study

Enrolled participants who are generally healthy and free of major chronic conditions will be randomized to receive either Commercial Native Starch or Extrusion Processed Starch first and then will be crossed over to receive the opposite Intervention. The study will consist of two clinical test visits of 120 minutes separated by a washout period of at least 24 hours.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adult males or non-pregnant females.
  • eligible to receive income in Canada.

Exclusion criteria

  • age less than 18 years
  • any known food allergies or intolerances to the investigational product
  • medications known to affect glucose tolerance -but stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable
  • known history of diabetes mellitus or the use of anti-hyperglycemic drugs or insulin to treat diabetes and related conditions
  • any major medical or surgical events requiring hospitalization within the preceding 3 months
  • the presence of disease or drug(s) which influence digestion and absorption of nutrients
  • the short-term use of systemic steroids or atypical antipsychotics (<4 weeks) (all of which have major effects on glucose and metabolism and body fat distribution)
  • any other medications or conditions which might, in the opinion of the Medical Director of INQUIS Clinical Research Ltd. (INQUIS), either 1) make participation dangerous to the subject or to others, or 2) affect the results
  • any subject who cannot or will not comply with the experimental procedures or do not follow INQUIS safety guidelines

Treatment and study plan

Commercial native starch without processing

Other

A food-grade commercial native starch without processing that has been rehydrated into a pudding for oral consumption.

Modified starch with extrusion processing

Other

A food-grade modified starch with extrusion processing that has been rehydrated into a pudding for oral consumption.

Primary outcomes

  1. Postprandial Glycemia

    Time frame: -5 to 120 minutes after intervention administration

    Incremental area under the curve for blood glucose over 120 minutes.

Secondary outcomes

  1. Incremental Blood Glucose

    Time frame: 0, 15, 30, 45, 60, 90, and 120 minutes after intervention administration

    Change in blood glucose from baseline at each time point

Sponsors and collaborators

Lead sponsor

INQUIS Clinical Research

Industry

Collaborators

  • University of Saskatchewan

Registry information

Official study title

The Effect of Starch Processing on Postprandial Blood Glucose in Humans

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
May 1, 2025

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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