- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02621307
Effect of Salba & Flax on Postprandial Glycemia and Subjective Satiety
December 1, 2015 updated by: Vladimir Vuksan, Unity Health Toronto
The Effect of Salba (Salvia Hispanica L) Versus Flax on Postprandial Blood Glucose Response and Subjective Appetite in Healthy Individuals
The purpose of this study is to determine whether drinks containing Salvia hispanica L (Salba) or Flax lower postprandial blood glucose levels and improve appetite in healthy individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Dietary fibre has been implicated in improving many risk factors associated with Type 2 Diabetes and Cardiovascular Disease (CVD).
However, on average, Norther Americans consume less than half of the recommended amount set by health agencies.
It has been proposed that the health benefits of dietary fibre may be attritbuted to rheological characteristics such as viscosity.
Salvia hispanica L (Salba) and Flax are nutritionally similar.
The primary objective of this research trial is to study the effects of Salba and Flax on postprandial glycemia and appetite in healthy individuals.
Study Type
Interventional
Enrollment (Actual)
15
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
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Toronto, Ontario, Canada, M5B 1W8
- 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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI less than 35 kg/m^2
Exclusion Criteria:
- known history of liver or kidney disease, diabetes, hypertension, stroke, or myocardial infarctions, thyroid disease, gastrointestinal disease, or AIDS
- subjects using medications or Natural Health Products
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
50g glucose 25g ground Salba (Salba Corporation Ltd, Buenos Aires, Argentina) 200ml water
|
Other Names:
|
Experimental: Flax
50g glucose 31g ground Flax (Bob's Red Mill Natural Raw Whole Flaxseed) 200ml water
|
|
Placebo Comparator: Control
50g glucose 200ml water
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Postprandial Blood Glucose
Time Frame: 2 Hours
|
At each visit, postprandial blood glucose will be measured via capillary blood samples, at 15, 30, 45, 60, 90, and 120 minutes after intake of test meals
|
2 Hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Subjective Satiety
Time Frame: 2 Hours
|
At each visit, subjective satiety (how hungry/full you feel) will be measured via questionnaires, at 15, 30, 45, 60, 90, and 120 minutes after intake of test meals
|
2 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
July 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
November 27, 2015
First Submitted That Met QC Criteria
December 1, 2015
First Posted (Estimate)
December 3, 2015
Study Record Updates
Last Update Posted (Estimate)
December 3, 2015
Last Update Submitted That Met QC Criteria
December 1, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLUSEED
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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