Evaluation of Carbohydrates Part 2

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

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

Conditions
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Gastro-Intestinal Tolerance

Intervention / Treatment
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* Other: CHO Control 1 and 2 Glucose
* Other: CHO Experimental 1 Slowly Digested
* Other: CHO Experimental 2 Digestion Resistant
* Other: CHO Experimental 3 Low Sugar
* Other: CHO Experimental 4 Maltodextrin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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