Type 2 DiabetesPhase 2NCT00362011
Effect of Chia Seeds (Salvia Hispanica L.) on Glucose Control in Patients With Type 2 Diabetes
A Phase 2 study testing Salba diet in people with Type 2 Diabetes, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether the addition of Salvia hispanica L. Alba (Salba) to the conventional treatment for diabetes is associated with improvement in major and emerging cardiovascular risk factors in people with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Salba diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Mar 2001to not given
- Phase
- Phase 2
- 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 35 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- All men or postmenopausal women with Type 2 diabetes optimally or suboptimally controlled (HbA1C < 9.0%) on oral hypoglycemic agents or diet only were asked to participate.
Who cannot join
- Those receiving insulin, alpha-glucosidase inhibitors, or hormone replacement therapy, with BMI>38 kg/m2, smoking or significant alcohol intake (>2 drinks/day), serum TG >4.0 mmol/L, and those with complications of diabetes were excluded. Subjects were also excluded if they regularly took fish oil and flax seed supplements or used steroids. Subjects were excluded during the course of the study if there were any changes to their regular antihypertensive, lipid, or oral hypoglycemic medications, if unable to consume >50% of supplements provided, had a significant weight change (defined as >2.5 kg), or if their level of physical activity did not remain constant over the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the addition of Salvia hispanica L. Alba (Salba) to the conventional treatment for diabetes is associated with improvement in major and emerging cardiovascular risk factors in people with type 2 diabetes.
Read the detailed description
Cohort studies have linked consumption of whole grain with a reduction in the risk of developing diabetes and heart disease. Grain of the plant Salvia hispanica alba (Salba) contain a high concentration of ω-3 fatty acids in addition to being a rich source of vegetable protein, fiber, calcium and antioxidants which have cardiovascular protective effect. To address the paucity of randomized, well-controlled clinical studies supporting the long-term cardioprotective benefits of whole grain we investigated the effects of a novel grain Salba in type 2 diabetes.
Comparison(s): Participants on a conventional diabetes diet (50% carbohydrate, 20% protein, 30% fat) receive either addition of Salba or matched control supplement for 12 weeks separated by a 4-week washout period.
- Conditions
- Type 2 Diabetes
- Being tested
- Salba diet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salba dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Secondary outcomes (3)
Efficacy - major and emerging risk factors for cardiovascular disease (blood pressure, Hs-C-reactive protein, coagulation factors)
safety (liver, kidney and haemostatic function)
compliance (plasma fatty-acids, returned supplements, diet records, body weight).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study startMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Vladimir Vuksan, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362011
- Sponsor's protocol ID
- 01-062
- Status last verified
- Feb 2001
- First submitted
- 8 Aug 2006
- Last updated
- 9 Aug 2006
- Results posted
- No
Publications
Vuksan V, Whitham D, Sievenpiper JL, Jenkins AL, Rogovik AL, Bazinet RP, Vidgen E, Hanna A. Supplementation of conventional therapy with the novel grain Salba (Salvia hispanica L.) improves major and emerging cardiovascular risk factors in type 2 diabetes: results of a randomized controlled trial. Diabetes Care. 2007 Nov;30(11):2804-10. doi: 10.2337/dc07-1144. Epub 2007 Aug 8.
PubMed 17686832
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chia Seeds (Salvia Hispanica L.) on Glucose Control in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00362011
- Acronym / sponsor ID
- 01-062
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Mar 2001
- First posted
- 9 Aug 2006 (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 the addition of Salvia hispanica L. Alba (Salba) to the conventional treatment for diabetes is associated with improvement in major and emerging cardiovascular risk factors in people with type 2 diabetes.
Detailed description
Cohort studies have linked consumption of whole grain with a reduction in the risk of developing diabetes and heart disease. Grain of the plant Salvia hispanica alba (Salba) contain a high concentration of ω-3 fatty acids in addition to being a rich source of vegetable protein, fiber, calcium and antioxidants which have cardiovascular protective effect. To address the paucity of randomized, well-controlled clinical studies supporting the long-term cardioprotective benefits of whole grain we investigated the effects of a novel grain Salba in type 2 diabetes.
Comparison(s): Participants on a conventional diabetes diet (50% carbohydrate, 20% protein, 30% fat) receive either addition of Salba or matched control supplement for 12 weeks separated by a 4-week washout period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All men or postmenopausal women with Type 2 diabetes optimally or suboptimally controlled (HbA1C < 9.0%) on oral hypoglycemic agents or diet only were asked to participate.
Key exclusion criteria (1 listed)
- Those receiving insulin, alpha-glucosidase inhibitors, or hormone replacement therapy, with BMI>38 kg/m2, smoking or significant alcohol intake (>2 drinks/day), serum TG >4.0 mmol/L, and those with complications of diabetes were excluded. Subjects were also excluded if they regularly took fish oil and flax seed supplements or used steroids. Subjects were excluded during the course of the study if there were any changes to their regular antihypertensive, lipid, or oral hypoglycemic medications, if unable to consume >50% of supplements provided, had a significant weight change (defined as >2.5 kg), or if their level of physical activity did not remain constant over the course of the study.
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 |
|---|---|---|
| Salba diet | Behavioural | – |
Primary outcome
Hemoglobin A1c
3 secondary outcomes
Efficacy - major and emerging risk factors for cardiovascular disease (blood pressure, Hs-C-reactive protein, coagulation factors)
safety (liver, kidney and haemostatic function)
compliance (plasma fatty-acids, returned supplements, diet records, body weight).
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 9 Aug 2006.
- Derived from this study: PubMed 17686832Vuksan V, Whitham D, Sievenpiper JL, Jenkins AL, Rogovik AL, Bazinet RP, Vidgen E, Hanna A. Supplementation of conventional therapy with the novel grain Salba (Salvia hispanica L.) improves major and emerging cardiovascular risk factors in type 2 diabetes: results of a randomized controlled trial. Diabetes Care. 2007 Nov;30(11):2804-10. doi: 10.2337/dc07-1144. Epub 2007 Aug 8.
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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.
Vladimir Vuksan, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Salba diet in people with Type 2 Diabetes, 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 1 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 9 Aug 2006. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Hemoglobin A1c. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00362011, which also lists 1 linked publication.
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 9 Aug 2006.