Blood Glucose Response of Processed Starch

Not Applicable

Completed

• Conditions: Glycemic Response
• Interventions: Other: Commercial native starch without processing; Other: Modified starch with extrusion processing

• Registration Number: NCT06048978
• Lead Sponsor: INQUIS Clinical Research

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Study Start: 2023-10-02
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Native Starch, then Processed Starch	Modified starch with extrusion processing	Participants will first receive the Commercial Native Starch in a fasting state in one clinical visit. After a washout of \>24 hours, the participants will then receive the Extrusion Processed Starch in a fasting state in one clinical visit.
Processed Starch, then Native Starch	Commercial native starch without processing	Participants will first receive the Extrusion Processed Starch in a fasting state in one clinical visit. After a washout of \>24 hours, the participants then will receive the Commercial Native Starch in a fasting state in one clinical visit.
Native Starch, then Processed Starch	Commercial native starch without processing	Participants will first receive the Commercial Native Starch in a fasting state in one clinical visit. After a washout of \>24 hours, the participants will then receive the Extrusion Processed Starch in a fasting state in one clinical visit.
Processed Starch, then Native Starch	Modified starch with extrusion processing	Participants will first receive the Extrusion Processed Starch in a fasting state in one clinical visit. After a washout of \>24 hours, the participants then will receive the Commercial Native Starch in a fasting state in one clinical visit.

Primary Outcome Measures

Name	Time	Method
Postprandial Glycemia	-5 to 120 minutes after intervention administration	Incremental area under the curve for blood glucose over 120 minutes.

Secondary Outcome Measures

Name	Time	Method
Incremental Blood Glucose	0, 15, 30, 45, 60, 90, and 120 minutes after intervention administration	Change in blood glucose from baseline at each time point

Trial Locations

Locations (1)

INQUIS Clinical Research Ltd.; 🇨🇦 Toronto, Ontario, Canada