NCT00841503

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

Enrollment Period

3.5 years

First QC Date

February 10, 2009

Last Update Submit

March 20, 2012

Conditions

Keywords

functional food study

Outcome Measures

Primary Outcomes (1)

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

    3 hour testing

Secondary Outcomes (1)

  • determine bioavailability of buckwheat bioactive compounds

    7 days

Study Arms (2)

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

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

Interventions

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

12 Participants with Type 2 diabetes12 healthy volunteers

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I.H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (23)

  • Kawa JM, Taylor CG, Przybylski R. Buckwheat concentrate reduces serum glucose in streptozotocin-diabetic rats. J Agric Food Chem. 2003 Dec 3;51(25):7287-91. doi: 10.1021/jf0302153.

    PMID: 14640572BACKGROUND
  • Qureshi AA, Sami SA, Khan FA. Effects of stabilized rice bran, its soluble and fiber fractions on blood glucose levels and serum lipid parameters in humans with diabetes mellitus Types I and II. J Nutr Biochem. 2002 Mar;13(3):175-187. doi: 10.1016/s0955-2863(01)00211-x.

    PMID: 11893482BACKGROUND
  • Knekt P, Kumpulainen J, Jarvinen R, Rissanen H, Heliovaara M, Reunanen A, Hakulinen T, Aromaa A. Flavonoid intake and risk of chronic diseases. Am J Clin Nutr. 2002 Sep;76(3):560-8. doi: 10.1093/ajcn/76.3.560.

    PMID: 12198000BACKGROUND
  • Thompson LU, Robb P, Serraino M, Cheung F. Mammalian lignan production from various foods. Nutr Cancer. 1991;16(1):43-52. doi: 10.1080/01635589109514139.

    PMID: 1656395BACKGROUND
  • Larner J, Huang LC, Schwartz CF, Oswald AS, Shen TY, Kinter M, Tang GZ, Zeller K. Rat liver insulin mediator which stimulates pyruvate dehydrogenase phosphate contains galactosamine and D-chiroinositol. Biochem Biophys Res Commun. 1988 Mar 30;151(3):1416-26. doi: 10.1016/s0006-291x(88)80520-5.

    PMID: 2833261BACKGROUND
  • Larner J, Huang LC, Suzuki S, Tang G, Zhang C, Schwartz CF, Romero G, Luttrell L, Kennington AS. Insulin mediators and the control of pyruvate dehydrogenase complex. Ann N Y Acad Sci. 1989;573:297-305. doi: 10.1111/j.1749-6632.1989.tb15006.x. No abstract available.

    PMID: 2517463BACKGROUND
  • Varela-Nieto I, Leon Y, Caro HN. Cell signalling by inositol phosphoglycans from different species. Comp Biochem Physiol B Biochem Mol Biol. 1996 Oct;115(2):223-41. doi: 10.1016/0305-0491(96)00087-9.

    PMID: 8939003BACKGROUND
  • Field MC. Is there evidence for phospho-oligosaccharides as insulin mediators? Glycobiology. 1997 Mar;7(2):161-8. doi: 10.1093/glycob/7.2.161-d. No abstract available.

    PMID: 9134421BACKGROUND
  • Jones DR, Varela-Nieto I. The role of glycosyl-phosphatidylinositol in signal transduction. Int J Biochem Cell Biol. 1998 Mar;30(3):313-26. doi: 10.1016/s1357-2725(97)00144-1.

    PMID: 9611774BACKGROUND
  • Oku A, Ueta K, Arakawa K, Ishihara T, Nawano M, Kuronuma Y, Matsumoto M, Saito A, Tsujihara K, Anai M, Asano T, Kanai Y, Endou H. T-1095, an inhibitor of renal Na+-glucose cotransporters, may provide a novel approach to treating diabetes. Diabetes. 1999 Sep;48(9):1794-800. doi: 10.2337/diabetes.48.9.1794.

    PMID: 10480610BACKGROUND
  • Adachi T, Yasuda K, Okamoto Y, Shihara N, Oku A, Ueta K, Kitamura K, Saito A, Iwakura I, Yamada Y, Yano H, Seino Y, Tsuda K. T-1095, a renal Na+-glucose transporter inhibitor, improves hyperglycemia in streptozotocin-induced diabetic rats. Metabolism. 2000 Aug;49(8):990-5. doi: 10.1053/meta.2000.7729.

    PMID: 10954015BACKGROUND
  • Ueta K, Ishihara T, Matsumoto Y, Oku A, Nawano M, Fujita T, Saito A, Arakawa K. Long-term treatment with the Na+-glucose cotransporter inhibitor T-1095 causes sustained improvement in hyperglycemia and prevents diabetic neuropathy in Goto-Kakizaki Rats. Life Sci. 2005 Apr 22;76(23):2655-68. doi: 10.1016/j.lfs.2004.09.038.

    PMID: 15792833BACKGROUND
  • Nawano M, Oku A, Ueta K, Umebayashi I, Ishirahara T, Arakawa K, Saito A, Anai M, Kikuchi M, Asano T. Hyperglycemia contributes insulin resistance in hepatic and adipose tissue but not skeletal muscle of ZDF rats. Am J Physiol Endocrinol Metab. 2000 Mar;278(3):E535-43. doi: 10.1152/ajpendo.2000.278.3.E535.

    PMID: 10710509BACKGROUND
  • Skrabanja V, Liljeberg Elmstahl HG, Kreft I, Bjorck IM. Nutritional properties of starch in buckwheat products: studies in vitro and in vivo. J Agric Food Chem. 2001 Jan;49(1):490-6. doi: 10.1021/jf000779w.

    PMID: 11170616BACKGROUND
  • Bray GA. Evaluation of obesity. Who are the obese? Postgrad Med. 2003 Dec;114(6):19-27, 38. doi: 10.3810/pgm.2003.12.1544.

    PMID: 14689721BACKGROUND
  • Ball GD, McCargar LJ. Childhood obesity in Canada: a review of prevalence estimates and risk factors for cardiovascular diseases and type 2 diabetes. Can J Appl Physiol. 2003 Feb;28(1):117-40. doi: 10.1139/h03-010.

    PMID: 12671200BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • Horbowicz M & Obendorf RL. (1994) Seed Sci Res 4: 385-405.

    BACKGROUND
  • Obendorf RL, Steadman KJ, Fuller DJ, Horbowicz M, Lewis BA. Molecular structure of fagopyritol A1 (O-alpha-D-galactopyranosyl-(1 --> 3)-D-chiro-inositol) by NMR. Carbohydr Res. 2000 Oct 6;328(4):623-7. doi: 10.1016/s0008-6215(00)00133-6.

    PMID: 11093720BACKGROUND
  • Steadman KJ, Burgoon MS, Schuster RL, Lewis BA, Edwardson SE, Obendorf RL. Fagopyritols, D-chiro-inositol, and other soluble carbohydrates in buckwheat seed milling fractions. J Agric Food Chem. 2000 Jul;48(7):2843-7. doi: 10.1021/jf990709t.

    PMID: 10898633BACKGROUND
  • Steadman KJ, Fuller DJ, Obendorf RL. Purification and molecular structure of two digalactosyl D-chiro-inositols and two trigalactosyl D-chiro-inositols from buckwheat seeds. Carbohydr Res. 2001 Mar 9;331(1):19-25. doi: 10.1016/s0008-6215(00)00320-7.

    PMID: 11284502BACKGROUND
  • Scheepers A, Joost HG, Schurmann A. The glucose transporter families SGLT and GLUT: molecular basis of normal and aberrant function. JPEN J Parenter Enteral Nutr. 2004 Sep-Oct;28(5):364-71. doi: 10.1177/0148607104028005364.

    PMID: 15449578BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

GlucoseSweetening Agents

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Peter C Zahradka, PhD

    Canadian Centre for Agri-Food Research in Health & Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Physiology

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

September 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 21, 2012

Record last verified: 2012-03

Locations