- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01579656
Effect of Flax, Poppy, Sesame & Salba on Postprandial Blood Glucose Response, Vascular, Appetite & Sensory Parameters
March 6, 2014 updated by: Vladimir Vuksan, Unity Health Toronto
The Effects of Four Commonly Consumed Seeds (Flax, Poppy, Sesame & Salba) on Postprandial Blood Glucose Response, Vascular, Appetite and Sensory Parameters in Healthy Individuals
Consumption of whole grains has been heavily endorsed by both government and major health agencies, as evidenced in Health Canada's Food Guide, the US Department of Agriculture's Food Pyramid, and the Heart and Stroke Foundation's healthy eating guide.
Whole grains have been championed for their proposed cardioprotective and weight control effects as suggested by epidemiological studies.
The health benefits of whole grain products may be attributable to their nutrient composition, which contains dietary fibre, protein and several essential nutrients.
There has also been a concurrent increase in seed consumption.
Seeds have a similar and potentially superior nutritional composition to whole grains and they are rich in mammalian lignans and polyunsaturated fats, especially the highly valued omega-3 fatty acids.
Preliminary studies on seeds have shown that they impart health benefits similar to those imparted by whole grains.
Consumer choices regarding seed consumption may be based on their potential health benefits.
Furthermore, they may also be affected by subjective sensory factors, such as appearance, taste and pre-conceived perceptions.
Therefore, this study will compare the health properties of four seeds and their effects on appetite and sensory parameters in healthy individuals.
These four seeds will be that of flax, poppy and sesame, due to their popularity and consumption as well as Salba, which has also recently received much attention for its associated health benefits.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, L3R 5G4
- St. Michael's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 18-65 years
- normal glycemic response
- BMI between 18.5 - 25 kg/m2
- peripheral systolic and diastolic blood pressure < 140mmHg and < 90mmHg
Exclusion Criteria:
- known history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, Celiac disease/gastrointestinal disease, or AIDS;
- allergies to any of the test products
- using prescription medications or Natural Health Products
- any condition which, in the opinion of the investigator, might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Salba
25g of ground Salba baked into a bran muffin
|
25g of ground Salba baked into a bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal) with the addition of flour, inulin or canola oil.
One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
Other Names:
|
Experimental: Poppy
25g of ground poppy seeds baked into a bran muffin
|
25g of ground Poppy Seeds baked into a bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal) with the addition of flour, inulin or canola oil.
One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
Other Names:
|
Experimental: Flaxseed
25g of ground flaxseed baked into a bran muffin
|
25g of ground Flaxseed baked into a bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal) with the addition of flour, inulin or canola oil.
One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
Other Names:
|
Experimental: Sesame
25g of ground sesame seeds baked into a bran muffin
|
25g of ground Sesame Seeds baked into a bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal) with the addition of flour, inulin or canola oil.
One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
Other Names:
|
Placebo Comparator: Wheat Bran
Bran muffin matched for total available carbohydrates, total dietary fibre and calories
|
Bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal).
One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial Blood Glucose
Time Frame: 3 hours
|
At each visit, postprandial blood glucose will be measured every 15 minutes over 3 hours.
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure
Time Frame: 3 hours
|
At each visit, brachial blood pressure will be measured every 30 minutes over 3 hours.
|
3 hours
|
Arterial Stiffness
Time Frame: 3 hours
|
At each visit, arterial stiffness (assessed by central augmentation index) will be measured every 30 minutes over 3 hours.
|
3 hours
|
Palatability
Time Frame: 3 hours
|
At each visit, participants will record their subjective ratings using a 100mm visual analogue scale and these ratings will be combined into a total subjective palatability score.
|
3 hours
|
Personal Preference
Time Frame: 3 hours
|
At each visit, participants will record their subjective ratings using a 100mm visual analogue scale and these ratings will be combined into a total subjective personal preference score.
|
3 hours
|
Satiety
Time Frame: 3 hours
|
At each visit, participants will record their subjective ratings using a 100mm visual analogue scale and these ratings will be combined into a total subjective appetite score.
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
August 26, 2011
First Submitted That Met QC Criteria
April 16, 2012
First Posted (Estimate)
April 18, 2012
Study Record Updates
Last Update Posted (Estimate)
March 7, 2014
Last Update Submitted That Met QC Criteria
March 6, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLUSEED-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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