Blood Glucose Response of Processed Starch

Glycemic Response Clinical Trial

Official title:

The Effect of Starch Processing on Postprandial Blood Glucose in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06048978
• Other study ID #: INQ-2330
• Status: Completed
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: October 2023
• Source: INQUIS Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glycemic Response

Intervention

Other:
• Commercial native starch without processing
A food-grade commercial native starch without processing that has been rehydrated into a pudding for oral consumption.
• Modified starch with extrusion processing
A food-grade modified starch with extrusion processing that has been rehydrated into a pudding for oral consumption.

Locations

Country	Name	City	State
Canada	INQUIS Clinical Research Ltd.	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
INQUIS Clinical Research	University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial Glycemia	Incremental area under the curve for blood glucose over 120 minutes.	-5 to 120 minutes after intervention administration
Secondary	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