Glycemic IndexNCT03508154
Evaluation of Carbohydrates - Glycemic Index
A study testing Experimental Nutritional Product in people with Glycemic Index, run by Abbott Nutrition at 1 site in Canada.
Trial summary
This study is an open-label with a randomized, cross-over design using standard GI methodology. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index
- What is being tested?
- Experimental Nutritional Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 7 May 2018to 22 May 2018
- 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
- Subjects are males or non-pregnant females in good health
- Subjects must be eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.
Who cannot join
- Subjects with any type of food allergy or known history of AIDS, hepatitis, diabetes or a heart condition
- Subjects 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: Glycemic Index of Nutrition Product Formulation
This study is an open-label with a randomized, cross-over design using standard GI methodology.
- Conditions
- Glycemic Index
- Being tested
- Control Meal 1, Control Meal 2, Experimental Nutritional Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Meal 1Other
carbohydrate test meal
Control Meal 2Other
carbohydrate test meal
Experimental Nutritional ProductOther
ready to drink nutritional formulation
| Study group | Role | What they receive |
|---|---|---|
| Control Meal 1 | Active comparator | Control carbohydrate solution Receives: Other: Control Meal 1 |
| Control Meal 2 | Active comparator | Control carbohydrate solution Receives: Other: Control Meal 2 |
| Experimental Nutritional Product | Experimental | Study nutritional formulation Receives: Other: Experimental Nutritional Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose response curve
area under the curve
Measured: 0 to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start7 May 2018
- Primary completion22 May 2018
- Study completion22 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic IndexStudies 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
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Dumas, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508154
- Sponsor's protocol ID
- DA19
- Status last verified
- May 2018
- First submitted
- 16 Apr 2018
- Last updated
- 30 May 2018
- 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 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Carbohydrates: Glycemic Index of Nutrition Product Formulation
- ClinicalTrials.gov ID
- NCT03508154
- Acronym / sponsor ID
- DA19
- Conditions
- Glycemic Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 7 May 2018 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 25 Apr 2018 (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.
This study is an open-label with a randomized, cross-over design using standard GI methodology.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Meal 1 | Active comparator | Other: Control Meal 1Control carbohydrate solution |
| Control Meal 2 | Active comparator | Other: Control Meal 2Control carbohydrate solution |
| Experimental Nutritional Product | Experimental | Other: Experimental Nutritional ProductStudy nutritional formulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects are males or non-pregnant females in good health
- Subjects must be eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.
Key exclusion criteria (2 listed)
- Subjects with any type of food allergy or known history of AIDS, hepatitis, diabetes or a heart condition
- Subjects 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 |
|---|---|---|
| Control Meal 1carbohydrate test meal | Other | Control Meal 1 |
| Control Meal 2carbohydrate test meal | Other | Control Meal 2 |
| Experimental Nutritional Productready to drink nutritional formulation | Other | Experimental Nutritional Product |
Primary outcome
Blood glucose response curve
Time frame: 0 to 120 minutes
area under the curve
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 30 May 2018.
- 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.
Anne Dumas 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 Experimental Nutritional Product in people with Glycemic Index, 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 30 May 2018. 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?
Blood glucose response curve (time frame: 0 to 120 minutes). 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 30 May 2018.