Blood Glucose Response of Processed Starch

The Effect of Starch Processing on Postprandial Blood Glucose in Humans

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.

Study Overview

• Status: Completed
• Conditions: Glycemic Response
• Intervention / Treatment: Other: Commercial native starch without processing; Other: Modified starch with extrusion processing

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2N8
      • INQUIS Clinical Research Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Native Starch, then Processed Starch; 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.	Other: Commercial native starch without processing; A food-grade commercial native starch without processing that has been rehydrated into a pudding for oral consumption.; Other: Modified starch with extrusion processing; A food-grade modified starch with extrusion processing that has been rehydrated into a pudding for oral consumption.
Experimental: Processed Starch, then Native Starch; 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.	Other: Commercial native starch without processing; A food-grade commercial native starch without processing that has been rehydrated into a pudding for oral consumption.; Other: Modified starch with extrusion processing; A food-grade modified starch with extrusion processing that has been rehydrated into a pudding for oral consumption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial Glycemia	Incremental area under the curve for blood glucose over 120 minutes.	-5 to 120 minutes after intervention administration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: INQUIS Clinical Research
• Collaborators: University of Saskatchewan
• Investigators: Principal Investigator: Thomas MS Wolever, MD, PhD, DM (Oxon), Inquis Clinical research

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Blood Glucose; Postprandial Glycemia
• Other Study ID Numbers: INQ-2330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No