Diabetes MellitusPhase 2LOSSNCT01403571
Effectiveness and Safety of Salba on Weight Loss in Overweight Individuals With Type 2 Diabetes
A Phase 2 study testing Salba (Salvia hispanica L.) in people with Diabetes Mellitus and Overweight, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Canadian statistics indicate that the incidence of obesity is increasing and that the occurrence of diabetes in obese individuals is 5-fold greater than those with a healthy weight, making weight control in this population particularly relevant. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Overweight, Obesity
- What is being tested?
- Salba (Salvia hispanica L.)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Aug 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Well-controlled type 2 diabetes for at least 1 year
- Treated with diet and/or oral hypoglycemic medications
- BMI 25-40 kg/m2
Who cannot join
- Weight change in the past three months >10% of body weight
- On insulin therapy
- Unstable angina, myocardial infarction or stroke (within 6 months)
- Planned surgery or pregnancy
- Blood pressure >160mmHg/100mmHg
- Surgical procedures for weight loss and concomitant use of medication or supplements that alter body weight or appetite
- ALA, dietary fibre, fish oil supplements or consuming cold-water fish more than three times per week
Trial locations and contacts
1 site in 1 country.
Canada1 site
Risk Factor Modification Centre, St. Michael's
Toronto, Ontario, M5B1W8
About this study
Official title: Efficacy and Safety of Whole Grain Salba (Salvia Hispanica L.) on Weight Loss in Overweight and Obese Individuals With Type 2 Diabetes
Canadian statistics indicate that the incidence of obesity is increasing and that the occurrence of diabetes in obese individuals is 5-fold greater than those with a healthy weight, making weight control in this population particularly relevant. Preliminary clinical data has shown that the whole grain, Salba, may improve type 2 diabetes control, reduce after-meal blood glucose, cardiovascular disease (CVD) risk factors and suppress appetite. Its use may therefore have potential implications in long-term weight management, while improving diabetes.
The objective of this research (weight loss) is to evaluate whether adding Salba to an energy reduced diet for six months will result in greater weight loss compared to control in overweight and obese individuals with type 2 diabetes. The study recruited 77 overweight or obese individuals with type 2 diabetes. They were instructed to follow a calorie restricted diet and their regular diabetes therapy together with regular exercise. Participants were randomly assigned to receive 30 g Salba/1000 kcal of daily energy requirements, or an oat bran control supplement matched for energy. The effect of the supplements on weight-loss (including waist circumference, % body fat) and glucose control (A1c, fasting glucose levels) will be assessed. In addition, related outcomes such as low-grade body inflammation, hunger-regulating hormones (ghrelin, adiponectin), safety measures (urea, creatinine, ALT and prothrombin time) and satiety scores were evaluated.
Modest weight loss has been associated with improved glucose control in individuals with type 2 diabetes. Addition of Salba to an energy reduced diet may facilitate greater weight loss and improve glycemic control and CVD risk factors compared to such a diet alone. Salba may also promote maintenance of weight loss and therefore help prevent weight gain by providing feelings of fullness that reduce appetite. In light of the high incidence of obesity in individuals with diabetes, Salba grain may be a useful addition to the diet.
- Conditions
- Diabetes Mellitus, Overweight, Obesity
- Being tested
- Salba (Salvia hispanica L.), Oat-based Control
- Medical subject headings
- Diabetes Mellitus, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salba (Salvia hispanica L.)Dietary supplement
30g/1000kcal/day over 24 wks
Oat-based ControlDietary supplement
Placebo: 36g/1000kcal/day over 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Salba supplement | Experimental | 30g/1000kal Receives: Dietary Supplement: Salba (Salvia hispanica L.) |
| Oat-bran based Control Supplement | Placebo comparator | 36g/1000kcal Receives: Dietary Supplement: Oat-based Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
24 week timeframe for Weightloss phase
Measured: 24 weeks
Secondary outcomes (9)
Body composition
24 week timeframe for Weightloss phase
Measured: 24 weeks
Blood sugar control
(HbA1c and Fasting glucose) 24 week timeframe for Weightloss phase
Measured: 24 weeks
Low grade body inflammation
hs-CRP levels
Measured: 24 weeks
serum ALT
Safety Measures
Measured: 24 weeks
Prothrombin time
Safety Measures
Measured: 24 weeks
serum creatinine
Safety Measures
Measured: 24 weeks
Blood urea
Safety Measures
Measured: 24 weeks
Satiety hormones
ghrelin, adiponectin
Measured: 24 weeks
Fatty Acids (% composition)
ALA (18:3 n-3), LA (18:2 n-6); Compliance measure
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startOct 2009
- Primary completionAug 2015
- Study completionAug 2015
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 Diabetes MellitusStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Diabetes Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403571
- Sponsor's protocol ID
- 2103038AJ
- Acronym
- LOSS
- Status last verified
- Oct 2016
- First submitted
- 25 Jul 2011
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Vuksan V, Jenkins AL, Brissette C, Choleva L, Jovanovski E, Gibbs AL, Bazinet RP, Au-Yeung F, Zurbau A, Ho HV, Duvnjak L, Sievenpiper JL, Josse RG, Hanna A. Salba-chia (Salvia hispanica L.) in the treatment of overweight and obese patients with type 2 diabetes: A double-blind randomized controlled trial. Nutr Metab Cardiovasc Dis. 2017 Feb;27(2):138-146. doi: 10.1016/j.numecd.2016.11.124. Epub 2016 Dec 9.
PubMed 28089080
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Whole Grain Salba (Salvia Hispanica L.) on Weight Loss in Overweight and Obese Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01403571
- Acronym / sponsor ID
- LOSS / 2103038AJ
- Conditions
- Diabetes Mellitus, Overweight, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Diabetes Association
- Study start
- Oct 2009
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Jul 2011 (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.
Canadian statistics indicate that the incidence of obesity is increasing and that the occurrence of diabetes in obese individuals is 5-fold greater than those with a healthy weight, making weight control in this population particularly relevant. Preliminary clinical data has shown that the whole grain, Salba, may improve type 2 diabetes control, reduce after-meal blood glucose, cardiovascular disease (CVD) risk factors and suppress appetite. Its use may therefore have potential implications in long-term weight management, while improving diabetes.
The objective of this research (weight loss) is to evaluate whether adding Salba to an energy reduced diet for six months will result in greater weight loss compared to control in overweight and obese individuals with type 2 diabetes. The study recruited 77 overweight or obese individuals with type 2 diabetes. They were instructed to follow a calorie restricted diet and their regular diabetes therapy together with regular exercise. Participants were randomly assigned to receive 30 g Salba/1000 kcal of daily energy requirements, or an oat bran control supplement matched for energy. The effect of the supplements on weight-loss (including waist circumference, % body fat) and glucose control (A1c, fasting glucose levels) will be assessed. In addition, related outcomes such as low-grade body inflammation, hunger-regulating hormones (ghrelin, adiponectin), safety measures (urea, creatinine, ALT and prothrombin time) and satiety scores were evaluated.
Modest weight loss has been associated with improved glucose control in individuals with type 2 diabetes. Addition of Salba to an energy reduced diet may facilitate greater weight loss and improve glycemic control and CVD risk factors compared to such a diet alone. Salba may also promote maintenance of weight loss and therefore help prevent weight gain by providing feelings of fullness that reduce appetite. In light of the high incidence of obesity in individuals with diabetes, Salba grain may be a useful addition to the diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salba supplement | Experimental | Dietary Supplement: Salba (Salvia hispanica L.)30g/1000kal |
| Oat-bran based Control Supplement | Placebo comparator | Dietary Supplement: Oat-based Control36g/1000kcal |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Well-controlled type 2 diabetes for at least 1 year
- Treated with diet and/or oral hypoglycemic medications
- BMI 25-40 kg/m2
Key exclusion criteria (7 listed)
- Weight change in the past three months >10% of body weight
- On insulin therapy
- Unstable angina, myocardial infarction or stroke (within 6 months)
- Planned surgery or pregnancy
- Blood pressure >160mmHg/100mmHg
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 (Salvia hispanica L.)30g/1000kcal/day over 24 wks | Dietary supplement | Salba supplement |
| Oat-based ControlPlacebo: 36g/1000kcal/day over 24 weeks | Dietary supplement | Oat-bran based Control Supplement |
Primary outcome
Weight
Time frame: 24 weeks
24 week timeframe for Weightloss phase
9 secondary outcomes
Body composition
Time frame: 24 weeks
Blood sugar control
Time frame: 24 weeks
Low grade body inflammation
Time frame: 24 weeks
serum ALT
Time frame: 24 weeks
Prothrombin time
Time frame: 24 weeks
serum creatinine
Time frame: 24 weeks
Blood urea
Time frame: 24 weeks
Satiety hormones
Time frame: 24 weeks
Fatty Acids (% composition)
Time frame: 24 weeks
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 5 Oct 2016.
- Derived from this study: PubMed 28089080Vuksan V, Jenkins AL, Brissette C, Choleva L, Jovanovski E, Gibbs AL, Bazinet RP, Au-Yeung F, Zurbau A, Ho HV, Duvnjak L, Sievenpiper JL, Josse RG, Hanna A. Salba-chia (Salvia hispanica L.) in the treatment of overweight and obese patients with type 2 diabetes: A double-blind randomized controlled trial. Nutr Metab Cardiovasc Dis. 2017 Feb;27(2):138-146. doi: 10.1016/j.numecd.2016.11.124. Epub 2016 Dec 9.
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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 2 study testing Salba (Salvia hispanica L.) in people with Diabetes Mellitus and Overweight, 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 3 inclusion and 7 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 5 Oct 2016. 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 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?
Weight (time frame: 24 weeks). 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 NCT01403571, 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 5 Oct 2016.