NCT03242122

Brief Summary

The study is open-label with a randomized, cross-over design using standard Gl methodology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

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

Study Start

First participant enrolled

July 17, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2017

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

1 month

First QC Date

July 31, 2017

Last Update Submit

August 31, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood glucose response curve

    area under the curve (AUG)

    0 to 120 minutes

Study Arms (6)

CHO Control 1 Glucose

ACTIVE COMPARATOR

25 g glucose

Other: CHO Control 1 and 2 Glucose

CHO Experimental 1 Slowly Digested

EXPERIMENTAL

25 g slowly-digested carbohydrate blend

Other: CHO Experimental 1 Slowly Digested

CHO Experimental 2 Digestion Resistant

EXPERIMENTAL

25 g digestion-resistant carbohydrate blend

Other: CHO Experimental 2 Digestion Resistant

CHO Experimental 3 Low Sugar

EXPERIMENTAL

25 g low sugar carbohydrate blend

Other: CHO Experimental 3 Low Sugar

CHO Experimental 4 Maltodextrin

EXPERIMENTAL

25 g maltodextrin

Other: CHO Experimental 4 Maltodextrin

CHO Control 2 Glucose

ACTIVE COMPARATOR

25 g glucose

Other: CHO Control 1 and 2 Glucose

Interventions

mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption

CHO Control 1 GlucoseCHO Control 2 Glucose

mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption

CHO Experimental 1 Slowly Digested

mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption

CHO Experimental 2 Digestion Resistant

mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption

CHO Experimental 3 Low Sugar

mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption

CHO Experimental 4 Maltodextrin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects are males or non-pregnant females in good health.
  • Subjects must be eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.

You may not qualify if:

  • Subject with any type of food allergy or with a known history of AIDS, hepatitis, diabetes or a heart condition.
  • Subject taking medication, or with any condition which might, in the opinion of the PI either make participation dangerous to the subject or to others or affect the results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glycemic Index Laboratories Inc

Toronto, Ontario, M5C 2N8, Canada

Location

Study Officials

  • Vikkie Mustad, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 8, 2017

Study Start

July 17, 2017

Primary Completion

August 18, 2017

Study Completion

August 18, 2017

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations