Gastro-Intestinal ToleranceNCT03293706
Evaluation of Carbohydrates Part 2
A study testing CHO Experimental 1 Slowly Digested, CHO Experimental 2 Digestion Resistant and CHO Experimental 3 Low Sugar in people with Gastro-Intestinal Tolerance, run by Abbott Nutrition at 1 site in Canada.
Trial summary
The study is single-blind with a randomized, cross-over design to evaluate gastrointestinal tolerance of carbohydrate blends. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastro-Intestinal Tolerance
- What is being tested?
- CHO Experimental 1 Slowly Digested, CHO Experimental 2 Digestion Resistant and CHO Experimental 3 Low Sugar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 21 Sep 2017to 15 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or non-pregnant females in good health.
- Eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Carbohydrates (CHO): Tolerance, Breath Hydrogen and Methane
The study is single-blind with a randomized, cross-over design to evaluate gastrointestinal tolerance of carbohydrate blends.
- Conditions
- Gastro-Intestinal Tolerance
- Being tested
- CHO Control 1 and 2 Glucose, CHO Experimental 1 Slowly Digested, CHO Experimental 2 Digestion Resistant, CHO Experimental 3 Low Sugar, CHO Experimental 4 Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHO Control 1 and 2 GlucoseOther
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
CHO Experimental 1 Slowly DigestedOther
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
CHO Experimental 2 Digestion ResistantOther
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
CHO Experimental 3 Low SugarOther
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
CHO Experimental 4 MaltodextrinOther
mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
| Study group | Role | What they receive |
|---|---|---|
| CHO Control 1 Glucose | Active comparator | 25 g glucose Receives: Other: CHO Control 1 and 2 Glucose |
| CHO Control 2 Glucose | Active comparator | 25 g glucose Receives: Other: CHO Control 1 and 2 Glucose |
| CHO Experimental 1 Slowly Digested | Experimental | 25 g slowly-digested carbohydrate blend Receives: Other: CHO Experimental 1 Slowly Digested |
| CHO Experimental 2 Digestion Resistant | Experimental | 25 g digestion-resistant carbohydrate blend Receives: Other: CHO Experimental 2 Digestion Resistant |
| CHO Experimental 3 Low Sugar | Experimental | 25 g low sugar carbohydrate blend Receives: Other: CHO Experimental 3 Low Sugar |
| CHO Experimental 4 Maltodextrin | Experimental | 25 g maltodextrin Receives: Other: CHO Experimental 4 Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath hydrogen
Assessed in exhaled gasses
Measured: 0 to 7 hours
Secondary outcomes (1)
GI tolerance symptoms
Assessed using a subject tolerance questionnaire
Measured: 0 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start21 Sep 2017
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Intestinal ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vikkie Mustad, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293706
- Sponsor's protocol ID
- BL37 Part 2
- Status last verified
- Nov 2017
- First submitted
- 18 Sep 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Carbohydrates (CHO): Tolerance, Breath Hydrogen and Methane
- ClinicalTrials.gov ID
- NCT03293706
- Acronym / sponsor ID
- BL37 Part 2
- Conditions
- Gastro-Intestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is single-blind with a randomized, cross-over design to evaluate gastrointestinal tolerance of carbohydrate blends.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CHO Control 1 Glucose | Active comparator | Other: CHO Control 1 and 2 Glucose25 g glucose |
| CHO Control 2 Glucose | Active comparator | Other: CHO Control 1 and 2 Glucose25 g glucose |
| CHO Experimental 1 Slowly Digested | Experimental | Other: CHO Experimental 1 Slowly Digested25 g slowly-digested carbohydrate blend |
| CHO Experimental 2 Digestion Resistant | Experimental | Other: CHO Experimental 2 Digestion Resistant25 g digestion-resistant carbohydrate blend |
| CHO Experimental 3 Low Sugar | Experimental | Other: CHO Experimental 3 Low Sugar25 g low sugar carbohydrate blend |
| CHO Experimental 4 Maltodextrin | Experimental | Other: CHO Experimental 4 Maltodextrin25 g maltodextrin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males or non-pregnant females in good health.
- Eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHO Control 1 and 2 Glucosemixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption | Other | CHO Control 1 Glucose, CHO Control 2 Glucose |
| CHO Experimental 1 Slowly Digestedmixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption | Other | CHO Experimental 1 Slowly Digested |
| CHO Experimental 2 Digestion Resistantmixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption | Other | CHO Experimental 2 Digestion Resistant |
| CHO Experimental 3 Low Sugarmixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption | Other | CHO Experimental 3 Low Sugar |
| CHO Experimental 4 Maltodextrinmixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption | Other | CHO Experimental 4 Maltodextrin |
Primary outcome
Breath hydrogen
Time frame: 0 to 7 hours
Assessed in exhaled gasses
1 secondary outcome
GI tolerance symptoms
Time frame: 0 to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikkie Mustad, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHO Experimental 1 Slowly Digested, CHO Experimental 2 Digestion Resistant and CHO Experimental 3 Low Sugar in people with Gastro-Intestinal Tolerance, run by Abbott Nutrition at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath hydrogen (time frame: 0 to 7 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.