Exploring Buckwheat's Glucose Lowering Potential

This study has been completed.
Sponsor:
Collaborator:
University of Manitoba
Information provided by (Responsible Party):
Dr.Peter Zahradka, St. Boniface General Hospital Research Centre
ClinicalTrials.gov Identifier:
NCT00841503
First received: February 10, 2009
Last updated: March 20, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by St. Boniface General Hospital Research Centre:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Population

A total of 24 volunteers were recruited from the community; 12 healthy volunteers and 12 volunteers with Type 2 Diabetes

Criteria

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
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: NCT00841503

Locations
Canada, Manitoba
I.H. Asper Clinical Research Institute
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
St. Boniface General Hospital Research Centre
University of Manitoba
Investigators
Principal Investigator: Peter C Zahradka, PhD Canadian Centre for Agri-Food Research in Health & Medicine
  More Information

Additional Information:
Publications:
Lu C et al. (1992) Proceedings of the 5th International Symposium on Buckwheat; Lin R, Zhou M, Tao Y, Li J, Zhang, Z. Eds; Agriculture Publishing House: Beijing,China; pp 458-464.
Wang J et al. (1992) Proceedings of the 5th International Symposium on Buckwheat; Lin R, Zhou M, Tao Y, Li J, Zhang, Z. Eds; Agriculture Publishing House: Beijing, China; pp 465-467.

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 July 23, 2014