Exploring Buckwheat's Glucose Lowering Potential
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Purpose
Bioactive components in buckwheat enhance insulin sensitivity in Type 2 diabetes by improving glucose uptake and utilization through a unique mechanism that operates independent of insulin.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Other: buckwheat, rice crackers, glucose, sugar substitute |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Double-Blind, Randomized, Controlled Study to Determine Buckwheat's Glucose Lowering Effects in Healthy Volunteers and Volunteers With Type 2 Diabetes |
- determine glucose-lowering potential of the buckwheat bioactive compound during acute phase testing in volunteers with Type 2 diabetes [ Time Frame: 3 hour testing ] [ Designated as safety issue: No ]
- determine bioavailability of buckwheat bioactive compounds [ Time Frame: 7 days ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | September 2008 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
12 healthy volunteers
Healthy volunteers are randomized to 1 of 4 products over 4 weekly visits: i)buckwheat crackers;ii)crackers without buckwheat; iii)oral glucose; iv) oral sugar substitute, followed by 7 days of buckwheat crackers.
|
Other: buckwheat, rice crackers, glucose, sugar substitute
crackers contain equal amounts of available carbohydrates; 50 mls of oral solution for both glucose and Splenda
|
|
12 Participants with Type 2 diabetes
Volunteers with type 2 diabetes are randomized to 1 of 4 products over 4 weekly visits: i)buckwheat crackers;ii)crackers without buckwheat; iii)oral glucose; iv) oral sugar substitute, followed by 7 days of buckwheat crackers.
|
Other: buckwheat, rice crackers, glucose, sugar substitute
crackers contain equal amounts of available carbohydrates; 50 mls of oral solution for both glucose and Splenda
|
Detailed Description:
This is a single site, double-blind, randomized, controlled study designed to explore buckwheat's glucose lowering effects in healthy volunteers and volunteers with type 2 diabetes. A total of 24 volunteers consisting of 12 volunteers (healthy and diabetic) per group for both the acute and chronic phases of testing will be recruited through advertisement from the local community.
In the acute testing phase, volunteers (healthy and diabetic) will be asked to attend 4 visits one week apart for the duration of 3 hours per visit. A fasting blood sample will be collected at each visit. At each visit, all volunteers will consume in random order 1 of the following 4 products: i) crackers containing buckwheat; ii) crackers without buckwheat); iii) 50 mls of oral solution containing glucose; or iv) 50 mls of oral solution containing the sugar substitute Splenda. The crackers will contain equal amounts of available carbohydrates. Blood sampling will occur at 15, 30, 45, 60 minutes, and then every 60 minutes for the remainder of the visit. Sampling (pre and post product consumption) will measure insulin, glucose, and various incretins. Open venous access will be secured after the first sample has been obtained to minimize the number of needle pricks. Total amount of blood obtained will not exceed 30 mls per visit.
In the chronic testing phase, volunteers (healthy and diabetic) will receive the crackers containing buckwheat for consumption each day for 7 days. Prior to food consumption, a fasting blood sample will be obtained each day and a urine sample will be collected on Days 1, 3, and 7 to assess bioavailability of buckwheat compounds (concentrations in blood and urine), insulin and glucose. Sampling for a lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides), liver (ALT), kidney (creatinine), adipose function (adipokines), various incretins, as well as inflammatory status (various cytokines) will be done on Day 1 and Day 7. Total amount of blood obtained will not exceed 30 mls per visit.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
A total of 24 volunteers were recruited from the community; 12 healthy volunteers and 12 volunteers with Type 2 Diabetes
Inclusion Criteria:
- aged 18 to 70 years
- normal glycated hemoglobin (<6% healthy, <7.5% diabetic)
- absence of chronic conditions (except Type 2 diabetes)
- must be able to read and sign consent
- must be able to comply with protocol requirements
Exclusion Criteria:
- allergies to eggs, buckwheat, rice flour, or sugar substitutes (Splenda)
- acute or chronic conditions (except Type 2 diabetes)
- blood glucose >10mmol/L at beginning of test session
- medications that affect glycemic control
Contacts and Locations| Canada, Manitoba | |
| I.H. Asper Clinical Research Institute | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Principal Investigator: | Peter C Zahradka, PhD | Canadian Centre for Agri-Food Research in Health & Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Dr.Peter Zahradka, Professor, Department of Physiology, St. Boniface General Hospital Research Centre |
| ClinicalTrials.gov Identifier: | NCT00841503 History of Changes |
| Other Study ID Numbers: | buckwheat study |
| Study First Received: | February 10, 2009 |
| Last Updated: | March 20, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by St. Boniface General Hospital Research Centre:
|
functional food study |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013