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

NCT01579656 | Completed Phase 1

• 1 other identifier: GLUSEED-2
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Postprandial Blood Glucose

  At each visit, postprandial blood glucose will be measured every 15 minutes over 3 hours.

  3 hours

Secondary Outcomes (5)

• Blood Pressure

  3 hours

• Arterial Stiffness

  3 hours

• Palatability

  3 hours

• Personal Preference

  3 hours

• Satiety

  3 hours

Study Arms (5)

Salba

EXPERIMENTAL

25g of ground Salba baked into a bran muffin

Dietary Supplement: Salba

Poppy

EXPERIMENTAL

25g of ground poppy seeds baked into a bran muffin

Dietary Supplement: Poppy

Flaxseed

EXPERIMENTAL

25g of ground flaxseed baked into a bran muffin

Dietary Supplement: Flaxseed

Sesame

EXPERIMENTAL

25g of ground sesame seeds baked into a bran muffin

Dietary Supplement: Sesame

Wheat Bran

PLACEBO COMPARATOR

Bran muffin matched for total available carbohydrates, total dietary fibre and calories

Dietary Supplement: Wheat Bran

Interventions

Salba DIETARY_SUPPLEMENT

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.

Also known as: Salba hispanica L.

Salba

Poppy DIETARY_SUPPLEMENT

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.

Also known as: Papaver somniferum L.

Poppy

Flaxseed DIETARY_SUPPLEMENT

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.

Also known as: Linum Usitatissimum

Flaxseed

Sesame DIETARY_SUPPLEMENT

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.

Also known as: Sesamum indicum

Sesame

Wheat Bran DIETARY_SUPPLEMENT

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.

Also known as: Quaker Bran Muffin Mix

Wheat Bran

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-65 years
• normal glycemic response
• BMI between 18.5 - 25 kg/m2
• peripheral systolic and diastolic blood pressure \< 140mmHg and \< 90mmHg

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, L3R 5G4, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

S-adenosyl-L-methionine (R,S)-reticuline 7-O-methyltransferase; Linseed Oil; Dietary Fiber

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Vladimir Vuksan, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Vladimir Vuksan

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: April 18, 2012
• Study Start: February 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

CA (1)