Effects of Novel Fiber on Glucose Homeostasis in Individuals at Risk for Diabetes
NCT ID: NCT00820807
Last Updated: 2011-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
60 participants
INTERVENTIONAL
2009-01-31
2009-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Novel Fiber on Glucose Metabolism and Insulin Sensitivity
NCT01375803
Effects of Dietary Fiber on Insulin Sensitivity
NCT01521806
Post-prandial Glycemic Response to Fiber in Healthy Adults
NCT03252704
Study to Assess Safety and Effect of a Prebiotic Fiber Meal Replacement Shake in Individuals With Type 2 Diabetes
NCT05110703
Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus
NCT02204384
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
3g/day
Novel dietary fiber
oral consumption in beverage
2
6g/day
Novel dietary fiber
oral consumption in beverage
Placebo beverage
0g/day
Placebo
oral consumption in beverage
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Novel dietary fiber
oral consumption in beverage
Novel dietary fiber
oral consumption in beverage
Placebo
oral consumption in beverage
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age: \>30 and \<65 years at randomization into this trial
* BMI: 25-35 kg/m2 at randomization into this trial
* Fasting blood glucose: 95-140 mg/dl (for those with glucose 95-99mg/dl, must have history of gestational diabetes or first degree relative (parent or sibling) with history of diabetes; for those with glucose 100-125 mg/dl, will be enrolled as the primary target for recruitment; for those with glucose 126-140 mg/dl (asymptomatic diabetes), must not have prior diagnosis of diabetes and must not have prior treatment/pharmacotherapy for diabetes)
* Good general health as evidenced by the medical history
* Blood chemistry and urinalysis results within normal ranges or within an acceptable range determined by the physician on site and/or in consultation with the Medical Monitor
* Available and willing to participate in the study for up to 15 weeks
* Willing to follow a weight-maintaining Lifestyle diet throughout the 12 week trial, maintain physical activity patterns at baseline levels throughout the study period, and not add new exercise routines, dietary supplements, vitamins or other unusual food products
* Willing to consume two 16 oz beverages every day with meals for 12 weeks and able to transport the test article
Exclusion Criteria
* Food allergy or sensitivity to any of the ingredients in the study product (e.g. Gluten sensitivity, celiac disease)
* Participation in another clinical trial that might interfere with this trial or exposure to any investigational agent within 30 days prior to first visit
* History of diabetes (subjects with a prior history of gestational diabetes may be enrolled if they had no pharmacologic treatment for diabetes since pregnancy)
* Treatment for diabetes or a related condition (e.g., polycystic ovary syndrome) with metformin, an oral agent, or insulin or other injections used for diabetes management
* Uncontrolled hypertension (i.e., systolic blood pressure \>160 mm Hg, or a diastolic blood pressure \>95 mmHg based on an average of 3 readings sitting)
* Fasting serum triglyceride value \>200 mg/dl (since changes in triglyceride values can affect glucose homeostasis)
* Untreated hypothyroidism with a TSH \> 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit
* Recent history of weight loss (\>4 kg in the past 3 months) or a significant variation in weight (\>4 kg in the past 3 months, for example, due to a medical condition such as pregnancy, or hormonal therapy)
* Use of medications or herbal remedies for weight loss (e.g., sibutramine, orlistat, amphetamines, phentermine, and ma huang) or use of these substances within the past 3 months
* Current or recent history (past 12 months) of drug, alcohol or chemical abuse. Alcohol abuse will be defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor)
* Pregnant, breast-feeding or female of child-bearing potential who is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
30 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cargill
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Louisville Metabolic and Atherosclerosis Research Center (LMARC)
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Harold E Bays, MD, FACP
Role: PRINCIPAL_INVESTIGATOR
Louisville Metabolic and Atherosclerosis Research Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Louisville Metabolic and Atherosclerosis Research Center (LMARC)
Louisville, Kentucky, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CFIS-08-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.