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Completed

NCT Number: NCT00841503

Exploring Buckwheat's Glucose Lowering Potential

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

I.H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buckwheat, rice crackers, glucose, sugar substitute

Other

crackers contain equal amounts of available carbohydrates; 50 mls of oral solution for both glucose and Splenda

Primary outcomes

  1. determine glucose-lowering potential of the buckwheat bioactive compound during acute phase testing in volunteers with Type 2 diabetes

    Time frame: 3 hour testing

Secondary outcomes

  1. determine bioavailability of buckwheat bioactive compounds

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

St. Boniface Hospital

Other

Collaborators

  • University of Manitoba

Registry information

Official study title

A Double-Blind, Randomized, Controlled Study to Determine Buckwheat's Glucose Lowering Effects in Healthy Volunteers and Volunteers With Type 2 Diabetes

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 11, 2009
Registry last updated
Mar 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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