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Stopped due to a non-safety-related issue with the beverage (test vehicle).
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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 | Other | oral consumption in beverage |
| |
| Novel dietary fiber |
| Measure | Description | Time Frame |
|---|---|---|
| Mean changes in fasting and post-glucose administration values for plasma glucose from baseline to end of study | 0 weeks, 6 weeks, 9 weeks,12 weeks | |
| Mean changes in fasting and post-glucose administration values for plasma insulin from baseline to end of study | 0 weeks, 6 weeks, 9 weeks,12 weeks | |
| Mean changes in blood HbA1c values from baseline to end of study | 0 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean changes from baseline to end of study in HOMA, a measure of insulin sensitivity | 0 weeks, 6 weeks, 9 weeks,12 weeks | |
| Mean changes from baseline for fasting serum total cholesterol, HDL-cholesterol, LDL-cholesterol and triglyceride values at 6 and 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisville Metabolic and Atherosclerosis Research Center (LMARC) | Louisville | Kentucky | 40213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 16541277 | Background | Lindstrom J, Peltonen M, Eriksson JG, Louheranta A, Fogelholm M, Uusitupa M, Tuomilehto J. High-fibre, low-fat diet predicts long-term weight loss and decreased type 2 diabetes risk: the Finnish Diabetes Prevention Study. Diabetologia. 2006 May;49(5):912-20. doi: 10.1007/s00125-006-0198-3. Epub 2006 Mar 16. |
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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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| Other |
oral consumption in beverage |
|
| Placebo | Other | oral consumption in beverage |
|
| 0 weeks, 6 weeks, 12 weeks |
| Percentage change and absolute change from baseline in body weight at each treatment visit | 0 weeks, 3 weeks, 6 weeks, 9 weeks, 12 weeks |
| Mean changes from baseline in waist circumference at selected visits | 0 weeks, 12 weeks |
| Mean changes in total body fat, lean tissue and abdominal fat as determined by DEXA [distribution or absolute changes] | 0 weeks, 12 weeks |
| 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. |
| 12740069 | Background | Murtaugh MA, Jacobs DR Jr, Jacob B, Steffen LM, Marquart L. Epidemiological support for the protection of whole grains against diabetes. Proc Nutr Soc. 2003 Feb;62(1):143-9. doi: 10.1079/pns2002223. |
| 17684198 | Background | Anderson JW, Conley SB, Nicholas AS. One hundred pound weight losses with an intensive behavioral program: changes in risk factors in 118 patients with long-term follow-up. Am J Clin Nutr. 2007 Aug;86(2):301-7. doi: 10.1093/ajcn/86.2.301. |
| 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. |
| 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. |
| 10857960 | Background | Vuksan V, Sievenpiper JL, Owen R, Swilley JA, Spadafora P, Jenkins DJ, Vidgen E, Brighenti F, Josse RG, Leiter LA, Xu Z, Novokmet R. Beneficial effects of viscous dietary fiber from Konjac-mannan in subjects with the insulin resistance syndrome: results of a controlled metabolic trial. Diabetes Care. 2000 Jan;23(1):9-14. doi: 10.2337/diacare.23.1.9. |
| 15536472 | Background | Kim JI, Kim JC, Kang MJ, Lee MS, Kim JJ, Cha IJ. Effects of pinitol isolated from soybeans on glycaemic control and cardiovascular risk factors in Korean patients with type II diabetes mellitus: a randomized controlled study. Eur J Clin Nutr. 2005 Mar;59(3):456-8. doi: 10.1038/sj.ejcn.1602081. |
| 10372241 | Background | Vuksan V, Jenkins DJ, Spadafora P, Sievenpiper JL, Owen R, Vidgen E, Brighenti F, Josse R, Leiter LA, Bruce-Thompson C. Konjac-mannan (glucomannan) improves glycemia and other associated risk factors for coronary heart disease in type 2 diabetes. A randomized controlled metabolic trial. Diabetes Care. 1999 Jun;22(6):913-9. doi: 10.2337/diacare.22.6.913. |
| 16785338 | Background | American Heart Association Nutrition Committee; Lichtenstein AH, Appel LJ, Brands M, Carnethon M, Daniels S, Franch HA, Franklin B, Kris-Etherton P, Harris WS, Howard B, Karanja N, Lefevre M, Rudel L, Sacks F, Van Horn L, Winston M, Wylie-Rosett J. Diet and lifestyle recommendations revision 2006: a scientific statement from the American Heart Association Nutrition Committee. Circulation. 2006 Jul 4;114(1):82-96. doi: 10.1161/CIRCULATIONAHA.106.176158. Epub 2006 Jun 19. |
| 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. |