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Effect of Flax, Poppy, Sesame & Salba on Postprandial Blood Glucose Response, Vascular, Appetite & Sensory Parameters

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vladimir Vuksan, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01579656
First received: August 26, 2011
Last updated: March 6, 2014
Last verified: March 2014

August 26, 2011
March 6, 2014
February 2011
April 2012   (final data collection date for primary outcome measure)
Postprandial Blood Glucose [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
At each visit, postprandial blood glucose will be measured every 15 minutes over 3 hours.
Same as current
Complete list of historical versions of study NCT01579656 on ClinicalTrials.gov Archive Site
  • Blood Pressure [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    At each visit, brachial blood pressure will be measured every 30 minutes over 3 hours.
  • Arterial Stiffness [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    At each visit, arterial stiffness (assessed by central augmentation index) will be measured every 30 minutes over 3 hours.
  • Palatability [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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.
  • Personal Preference [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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.
  • Satiety [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Effect of Flax, Poppy, Sesame & Salba on Postprandial Blood Glucose Response, Vascular, Appetite & Sensory Parameters
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Cardiovascular Diseases
  • Dietary Supplement: Salba
    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 Name: Salba hispanica L.
  • Dietary Supplement: Poppy
    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 Name: Papaver somniferum L.
  • Dietary Supplement: Flaxseed
    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 Name: Linum Usitatissimum
  • Dietary Supplement: Sesame
    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 Name: Sesamum indicum
  • Dietary Supplement: Wheat Bran
    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 Name: Quaker Bran Muffin Mix
  • Experimental: Salba
    25g of ground Salba baked into a bran muffin
    Intervention: Dietary Supplement: Salba
  • Experimental: Poppy
    25g of ground poppy seeds baked into a bran muffin
    Intervention: Dietary Supplement: Poppy
  • Experimental: Flaxseed
    25g of ground flaxseed baked into a bran muffin
    Intervention: Dietary Supplement: Flaxseed
  • Experimental: Sesame
    25g of ground sesame seeds baked into a bran muffin
    Intervention: Dietary Supplement: Sesame
  • Placebo Comparator: Wheat Bran
    Bran muffin matched for total available carbohydrates, total dietary fibre and calories
    Intervention: Dietary Supplement: Wheat Bran
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
August 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01579656
GLUSEED-2
No
Vladimir Vuksan, St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
Not Provided
Principal Investigator: Vladimir Vuksan, PhD St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP