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| Sponsor: | Cargill |
|---|---|
| Information provided by: | Cargill |
| ClinicalTrials.gov Identifier: | NCT00820807 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Insulin Resistance |
Other: Novel dietary fiber Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Novel Fiber Effects on Glucose Metabolism and Insulin Sensitivity for Individuals at High Risk for Diabetes: a Randomized, Placebo-controlled, Double-blind, Parallel Group Clinical Trial |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2009 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
3g/day
|
Other: Novel dietary fiber
oral consumption in beverage
|
|
Experimental: 2
6g/day
|
Other: Novel dietary fiber
oral consumption in beverage
|
|
Placebo Comparator: Placebo beverage
0g/day
|
Other: Placebo
oral consumption in beverage
|
Eligibility| Ages Eligible for Study: | 30 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Kentucky | |
| Louisville Metabolic and Atherosclerosis Research Center (LMARC) | |
| Louisville, Kentucky, United States, 40213 | |
| Principal Investigator: | Harold E Bays, MD, FACP | Louisville Metabolic and Atherosclerosis Research Center |
More Information
| Responsible Party: | Harold E. Bays, MD, FACP/ Medical Director and President, Louisville Metabolic and Atherosclerosis Research Center (LMARC) |
| ClinicalTrials.gov Identifier: | NCT00820807 History of Changes |
| Other Study ID Numbers: | CFIS-08-003 |
| Study First Received: | January 8, 2009 |
| Last Updated: | June 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
dietary fiber fiber insulin sensitivity insulin resistance glucose metabolism |
|
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |