Back to resultsEffect of Salba & Flax on Postprandial Glycemia and Subjective Satiety
Primary Purpose
Hyperglycemia, Postprandial
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Salba
Flax
Control
Sponsored by
About this trial
This is an interventional prevention trial for Hyperglycemia, Postprandial focused on measuring postprandial glycemia, subjective appetite, Salba, Flax
Eligibility Criteria
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
Sites / Locations
- St. Michael's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Salba
Flax
Control
Arm Description
50g glucose 25g ground Salba (Salba Corporation Ltd, Buenos Aires, Argentina) 200ml water
50g glucose 31g ground Flax (Bob's Red Mill Natural Raw Whole Flaxseed) 200ml water
50g glucose 200ml water
Outcomes
Primary Outcome Measures
Change in Postprandial Blood Glucose
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
Secondary Outcome Measures
Change in Subjective Satiety
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
Full Information
NCT ID
NCT02621307
First Posted
November 27, 2015
Last Updated
December 1, 2015
Sponsor
Unity Health Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02621307
Brief Title
Effect of Salba & Flax on Postprandial Glycemia and Subjective Satiety
Official Title
The Effect of Salba (Salvia Hispanica L) Versus Flax on Postprandial Blood Glucose Response and Subjective Appetite in Healthy Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unity Health Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Postprandial
Keywords
postprandial glycemia, subjective appetite, Salba, Flax
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salba
Arm Type
Experimental
Arm Description
50g glucose 25g ground Salba (Salba Corporation Ltd, Buenos Aires, Argentina) 200ml water
Arm Title
Flax
Arm Type
Experimental
Arm Description
50g glucose 31g ground Flax (Bob's Red Mill Natural Raw Whole Flaxseed) 200ml water
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
50g glucose 200ml water
Intervention Type
Dietary Supplement
Intervention Name(s)
Salba
Other Intervention Name(s)
Salvia hispanica L
Intervention Type
Dietary Supplement
Intervention Name(s)
Flax
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Other Intervention Name(s)
Glucose
Primary Outcome Measure Information:
Title
Change in Postprandial Blood Glucose
Description
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
Time Frame
2 Hours
Secondary Outcome Measure Information:
Title
Change in Subjective Satiety
Description
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
Time Frame
2 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effect of Salba & Flax on Postprandial Glycemia and Subjective Satiety
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