NCT06048978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

September 15, 2023

Last Update Submit

April 29, 2025

Conditions

Glycemic Response

Keywords

Postprandial GlycemiaBlood Glucose

Outcome Measures

Primary Outcomes (1)

  • Postprandial Glycemia

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

    -5 to 120 minutes after intervention administration

Secondary Outcomes (1)

  • Incremental Blood Glucose

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

Study Arms (2)

Native Starch, then Processed Starch

EXPERIMENTAL

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 processingOther: Modified starch with extrusion processing

Processed Starch, then Native Starch

EXPERIMENTAL

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 processingOther: Modified starch with extrusion processing

Interventions

Commercial native starch without processingOTHER

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

Native Starch, then Processed StarchProcessed Starch, then Native Starch
Modified starch with extrusion processingOTHER

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

Native Starch, then Processed StarchProcessed Starch, then Native Starch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INQUIS Clinical Research Ltd.

Toronto, Ontario, M5C 2N8, Canada

Location

Study Officials

  • Thomas MS Wolever, MD, PhD, DM (Oxon)

    INQUIS Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 21, 2023

Study Start

October 2, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)