Evaluation of Carbohydrates Part 2

December 14, 2017 updated by: Abbott Nutrition

Evaluation of Carbohydrates (CHO): Tolerance, Breath Hydrogen and Methane

The study is single-blind with a randomized, cross-over design to evaluate gastrointestinal tolerance of carbohydrate blends.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C 2N8
        • Glycemic Index Laboratories, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or non-pregnant females in good health.
  • Eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.

Exclusion Criteria:

  • Subject with any type of food allergy or with a known history of AIDS, hepatitis, diabetes, cardio-vascular disease or GI disease.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CHO Control 1 Glucose
25 g glucose
Other: CHO Control 1 and 2 Glucose
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
Active Comparator: CHO Control 2 Glucose
25 g glucose
Other: CHO Control 1 and 2 Glucose
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
Experimental: CHO Experimental 1 Slowly Digested
25 g slowly-digested carbohydrate blend
Other: CHO Experimental 1 Slowly Digested
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
Experimental: CHO Experimental 2 Digestion Resistant
25 g digestion-resistant carbohydrate blend
Other: CHO Experimental 2 Digestion Resistant
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
Experimental: CHO Experimental 3 Low Sugar
25 g low sugar carbohydrate blend
Other: CHO Experimental 3 Low Sugar
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
Experimental: CHO Experimental 4 Maltodextrin
25 g maltodextrin
Other: CHO Experimental 4 Maltodextrin
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breath hydrogen
Time Frame: 0 to 7 hours
Assessed in exhaled gasses
0 to 7 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GI tolerance symptoms
Time Frame: 0 to 48 hours
Assessed using a subject tolerance questionnaire
0 to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2017

Primary Completion (Actual)

November 15, 2017

Study Completion (Actual)

November 15, 2017

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 26, 2017

Study Record Updates

Last Update Posted (Actual)

December 18, 2017

Last Update Submitted That Met QC Criteria

December 14, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • BL37 Part 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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