Evaluation of Carbohydrates Part 2

Gastro-Intestinal Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293706
• Other study ID #: BL37 Part 2
• Status: Completed
• Phase: N/A
• First received: September 18, 2017
• Last updated: December 14, 2017
• Start date: September 21, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: November 2017
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 15, 2017
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastro-Intestinal Tolerance

Intervention

Other:
• CHO Control 1 and 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
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption

Locations

Country	Name	City	State
Canada	Glycemic Index Laboratories, Inc.	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath hydrogen	Assessed in exhaled gasses	0 to 7 hours
Secondary	GI tolerance symptoms	Assessed using a subject tolerance questionnaire	0 to 48 hours