Evaluation of Carbohydrates Part 2

Not Applicable

Completed

• Conditions: Gastro-Intestinal Tolerance
• Interventions: Other: CHO Control 1 and 2 Glucose; Other: CHO Experimental 3 Low Sugar; Other: CHO Experimental 2 Digestion Resistant; Other: CHO Experimental 1 Slowly Digested; Other: CHO Experimental 4 Maltodextrin

• Registration Number: NCT03293706
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-18
• Study Start: 2017-09-21
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-26
• Status Verified: 2017-11
• Primary Completion: 2017-11-15
• Study Completion: 2017-11-15
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CHO Control 1 Glucose	CHO Control 1 and 2 Glucose	25 g glucose
CHO Control 2 Glucose	CHO Control 1 and 2 Glucose	25 g glucose
CHO Experimental 3 Low Sugar	CHO Experimental 3 Low Sugar	25 g low sugar carbohydrate blend
CHO Experimental 2 Digestion Resistant	CHO Experimental 2 Digestion Resistant	25 g digestion-resistant carbohydrate blend
CHO Experimental 1 Slowly Digested	CHO Experimental 1 Slowly Digested	25 g slowly-digested carbohydrate blend
CHO Experimental 4 Maltodextrin	CHO Experimental 4 Maltodextrin	25 g maltodextrin

Primary Outcome Measures

Name	Time	Method
Breath hydrogen	0 to 7 hours	Assessed in exhaled gasses

Secondary Outcome Measures

Name	Time	Method
GI tolerance symptoms	0 to 48 hours	Assessed using a subject tolerance questionnaire

Trial Locations

Locations (1)

Glycemic Index Laboratories, Inc.; 🇨🇦 Toronto, Ontario, Canada