Evaluation of Carbohydrates Part 2
Evaluation of Carbohydrates (CHO): Tolerance, Breath Hydrogen and Methane
1 other identifier
interventional
13
1 country
1
Brief Summary
The study is single-blind with a randomized, cross-over design to evaluate gastrointestinal tolerance of carbohydrate blends.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2017
CompletedStudy Start
First participant enrolled
September 21, 2017
CompletedFirst Posted
Study publicly available on registry
September 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2017
CompletedDecember 18, 2017
November 1, 2017
2 months
September 18, 2017
December 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Breath hydrogen
Assessed in exhaled gasses
0 to 7 hours
Secondary Outcomes (1)
GI tolerance symptoms
0 to 48 hours
Study Arms (6)
CHO Control 1 Glucose
ACTIVE COMPARATOR25 g glucose
CHO Control 2 Glucose
ACTIVE COMPARATOR25 g glucose
CHO Experimental 1 Slowly Digested
EXPERIMENTAL25 g slowly-digested carbohydrate blend
CHO Experimental 2 Digestion Resistant
EXPERIMENTAL25 g digestion-resistant carbohydrate blend
CHO Experimental 3 Low Sugar
EXPERIMENTAL25 g low sugar carbohydrate blend
CHO Experimental 4 Maltodextrin
EXPERIMENTAL25 g maltodextrin
Interventions
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
Eligibility Criteria
You may qualify if:
- Males or non-pregnant females in good health.
- Eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (1)
Glycemic Index Laboratories, Inc.
Toronto, Ontario, M5C 2N8, Canada
Study Officials
- STUDY CHAIR
Vikkie Mustad, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2017
First Posted
September 26, 2017
Study Start
September 21, 2017
Primary Completion
November 15, 2017
Study Completion
November 15, 2017
Last Updated
December 18, 2017
Record last verified: 2017-11