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OpenTrials
Completed

NCT Number: NCT03293706

Evaluation of Carbohydrates Part 2

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

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Key information

Conditions

Gastro-Intestinal Tolerance

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glycemic Index Laboratories, Inc.

Toronto, Ontario, M5C 2N8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHO Control 1 and 2 Glucose

Other

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

CHO Experimental 1 Slowly Digested

Other

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

CHO Experimental 2 Digestion Resistant

Other

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

CHO Experimental 3 Low Sugar

Other

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

CHO Experimental 4 Maltodextrin

Other

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

Primary outcomes

  1. Breath hydrogen

    Time frame: 0 to 7 hours

    Assessed in exhaled gasses

Secondary outcomes

  1. GI tolerance symptoms

    Time frame: 0 to 48 hours

    Assessed using a subject tolerance questionnaire

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2017
Registry last updated
Dec 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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