Hyperglycemia, PostprandialPhase 1NCT02621307
Effect of Salba & Flax on Postprandial Glycemia and Subjective Satiety
A Phase 1 study testing Salba and Flax in people with Hyperglycemia, Postprandial, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether drinks containing Salvia hispanica L (Salba) or Flax lower postprandial blood glucose levels and improve appetite in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Postprandial
- What is being tested?
- Salba and Flax
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Jul 2011
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI less than 35 kg/m^2
Who cannot join
- known history of liver or kidney disease, diabetes, hypertension, stroke, or myocardial infarctions, thyroid disease, gastrointestinal disease, or AIDS
- subjects using medications or Natural Health Products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Salba (Salvia Hispanica L) Versus Flax on Postprandial Blood Glucose Response and Subjective Appetite in Healthy Individuals
The purpose of this study is to determine whether drinks containing Salvia hispanica L (Salba) or Flax lower postprandial blood glucose levels and improve appetite in healthy individuals.
Read the detailed description
Dietary fibre has been implicated in improving many risk factors associated with Type 2 Diabetes and Cardiovascular Disease (CVD). However, on average, Norther Americans consume less than half of the recommended amount set by health agencies. It has been proposed that the health benefits of dietary fibre may be attritbuted to rheological characteristics such as viscosity. Salvia hispanica L (Salba) and Flax are nutritionally similar. The primary objective of this research trial is to study the effects of Salba and Flax on postprandial glycemia and appetite in healthy individuals.
- Conditions
- Hyperglycemia, Postprandial
- Being tested
- Salba, Flax, Control
- Keywords
- postprandial glycemia, subjective appetite, Salba, Flax
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbaDietary supplement
Also called Salvia hispanica L
FlaxDietary supplement
ControlDietary supplement
Also called Glucose
| Study group | Role | What they receive |
|---|---|---|
| Salba | Experimental | 50g glucose 25g ground Salba (Salba Corporation Ltd, Buenos Aires, Argentina) 200ml water Receives: Dietary Supplement: Salba |
| Flax | Experimental | 50g glucose 31g ground Flax (Bob's Red Mill Natural Raw Whole Flaxseed) 200ml water Receives: Dietary Supplement: Flax |
| Control | Placebo comparator | 50g glucose 200ml water Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Postprandial Blood Glucose
At each visit, postprandial blood glucose will be measured via capillary blood samples, at 15, 30, 45, 60, 90, and 120 minutes after intake of test meals
Measured: 2 Hours
Secondary outcomes (1)
Change in Subjective Satiety
At each visit, subjective satiety (how hungry/full you feel) will be measured via questionnaires, at 15, 30, 45, 60, 90, and 120 minutes after intake of test meals
Measured: 2 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJul 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycemia, PostprandialStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Vuksan, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621307
- Sponsor's protocol ID
- GLUSEED
- Status last verified
- Nov 2015
- First submitted
- 27 Nov 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Salba (Salvia Hispanica L) Versus Flax on Postprandial Blood Glucose Response and Subjective Appetite in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02621307
- Acronym / sponsor ID
- GLUSEED
- Conditions
- Hyperglycemia, Postprandial
- Keywords
- postprandial glycemia, subjective appetite, Salba, Flax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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 purpose of this study is to determine whether drinks containing Salvia hispanica L (Salba) or Flax lower postprandial blood glucose levels and improve appetite in healthy individuals.
Detailed description
Dietary fibre has been implicated in improving many risk factors associated with Type 2 Diabetes and Cardiovascular Disease (CVD). However, on average, Norther Americans consume less than half of the recommended amount set by health agencies. It has been proposed that the health benefits of dietary fibre may be attritbuted to rheological characteristics such as viscosity. Salvia hispanica L (Salba) and Flax are nutritionally similar. The primary objective of this research trial is to study the effects of Salba and Flax on postprandial glycemia and appetite in healthy individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Salba | Experimental | Dietary Supplement: Salba50g glucose 25g ground Salba (Salba Corporation Ltd, Buenos Aires, Argentina) 200ml water |
| Flax | Experimental | Dietary Supplement: Flax50g glucose 31g ground Flax (Bob's Red Mill Natural Raw Whole Flaxseed) 200ml water |
| Control | Placebo comparator | Dietary Supplement: Control50g glucose 200ml water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI less than 35 kg/m^2
Key exclusion criteria (2 listed)
- known history of liver or kidney disease, diabetes, hypertension, stroke, or myocardial infarctions, thyroid disease, gastrointestinal disease, or AIDS
- subjects using medications or Natural Health Products
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 |
|---|---|---|
| SalbaAlso: Salvia hispanica L | Dietary supplement | Salba |
| Flax | Dietary supplement | Flax |
| ControlAlso: Glucose | Dietary supplement | Control |
Primary outcome
Change in Postprandial Blood Glucose
Time frame: 2 Hours
At each visit, postprandial blood glucose will be measured via capillary blood samples, at 15, 30, 45, 60, 90, and 120 minutes after intake of test meals
1 secondary outcome
Change in Subjective Satiety
Time frame: 2 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 3 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Salba and Flax in people with Hyperglycemia, Postprandial, run by Unity Health Toronto 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 1 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 3 Dec 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Postprandial Blood Glucose (time frame: 2 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 3 Dec 2015.