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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
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Dietary Supplement: Salba
Dietary Supplement: Poppy
Dietary Supplement: Flaxseed
Dietary Supplement: Sesame
Dietary Supplement: Wheat Bran
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Effects of Four Commonly Consumed Seeds (Flax, Poppy, Sesame & Salba) on Postprandial Blood Glucose Response, Vascular, Appetite and Sensory Parameters in Healthy Individuals

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 21
Study Start Date: February 2011
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Salba
25g of ground Salba baked into a bran muffin
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.
Experimental: Poppy
25g of ground poppy seeds baked into a bran muffin
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.
Experimental: Flaxseed
25g of ground flaxseed baked into a bran muffin
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
Experimental: Sesame
25g of ground sesame seeds baked into a bran muffin
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
Placebo Comparator: Wheat Bran
Bran muffin matched for total available carbohydrates, total dietary fibre and calories
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579656

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, L3R 5G4
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Vladimir Vuksan, PhD St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: Vladimir Vuksan, Dr. Vladimir Vuksan, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01579656     History of Changes
Other Study ID Numbers: GLUSEED-2
Study First Received: August 26, 2011
Last Updated: March 6, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014