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This study will critically evaluate the effects of a novel dietary fiber administered to subjects at high risk for developing diabetes to determine if this intervention will improve insulin sensitivity compared to control product administration and, thus, decrease risk for developing diabetes.
The hypothesis is that consuming this novel fiber twice a day for 12 weeks will significantly decrease fasting plasma glucose, insulin and glycosylated hemoglobin values in pre-diabetic subjects (i.e. subjects with fasting plasma glucose levels 95-140 mg/dl at screening) compared to consumption of the control product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 3g/day |
|
| 2 | Experimental | 6g/day |
|
| Placebo beverage | Placebo Comparator | 0g/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel dietary fiber | Dietary Supplement | oral consumption in beverage |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean changes in fasting and post-glucose administration values for plasma glucose from baseline to end of study | 0, 6, 9, 12 weeks | |
| Mean changes in fasting and post-glucose administration values for plasma insulin from baseline to end of study | 0, 6, 9, 12 weeks | |
| Mean changes in blood HbA1c values from baseline to end of study | 0, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean changes from baseline to end of study in HOMA | 0, 6, 9, 12 weeks | |
| Percentage change and absolute change from baseline in body weight | 0, 3, 6, 9, 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harold E Bays, MD, FACP | Louisville Metabolic and Atherosclerosis Research Center | Principal Investigator |
| Dale R Wilson, MD, CCFP(EM), FCFP | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisville Metabolic and Atherosclerosis Research Center | Louisvile | Kentucky | 40213 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16567814 | Background | Weickert MO, Mohlig M, Schofl C, Arafat AM, Otto B, Viehoff H, Koebnick C, Kohl A, Spranger J, Pfeiffer AF. Cereal fiber improves whole-body insulin sensitivity in overweight and obese women. Diabetes Care. 2006 Apr;29(4):775-80. doi: 10.2337/diacare.29.04.06.dc05-2374. | |
| 10799374 | Background | Lu ZX, Walker KZ, Muir JG, Mascara T, O'Dea K. Arabinoxylan fiber, a byproduct of wheat flour processing, reduces the postprandial glucose response in normoglycemic subjects. Am J Clin Nutr. 2000 May;71(5):1123-8. doi: 10.1093/ajcn/71.5.1123. |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Novel dietary fiber |
| Dietary Supplement |
Oral consumption in beverage |
|
| Placebo | Other | Oral consumption in beverage |
|
| Mean changes from baseline in waist circumference |
| 0, 12 weeks |
| Mean changes in total body fat, lean tissue and abdominal fat as determined by DEXA [distribution or absolute changes] | 0, 12 weeks |
| KGK Synergize Inc. |
| London |
| Ontario |
| N6A 5R8 |
| Canada |
| 14559925 | Background | Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003 Oct;22(5):331-9. doi: 10.1080/07315724.2003.10719316. |
| 15930484 | Background | Behall KM, Scholfield DJ, Hallfrisch J. Comparison of hormone and glucose responses of overweight women to barley and oats. J Am Coll Nutr. 2005 Jun;24(3):182-8. doi: 10.1080/07315724.2005.10719464. |
| 12080401 | Background | Jenkins AL, Jenkins DJ, Zdravkovic U, Wursch P, Vuksan V. Depression of the glycemic index by high levels of beta-glucan fiber in two functional foods tested in type 2 diabetes. Eur J Clin Nutr. 2002 Jul;56(7):622-8. doi: 10.1038/sj.ejcn.1601367. |
| 17445284 | Background | Keenan JM, Goulson M, Shamliyan T, Knutson N, Kolberg L, Curry L. The effects of concentrated barley beta-glucan on blood lipids in a population of hypercholesterolaemic men and women. Br J Nutr. 2007 Jun;97(6):1162-8. doi: 10.1017/S0007114507682968. Epub 2007 Apr 20. |
| 21846371 | Derived | Bays H, Frestedt JL, Bell M, Williams C, Kolberg L, Schmelzer W, Anderson JW. Reduced viscosity Barley beta-Glucan versus placebo: a randomized controlled trial of the effects on insulin sensitivity for individuals at risk for diabetes mellitus. Nutr Metab (Lond). 2011 Aug 16;8:58. doi: 10.1186/1743-7075-8-58. |