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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: | Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
3g/day
|
Other: Novel dietary fiber
oral consumption in beverage
|
|
2: Experimental
6g/day
|
Other: Novel dietary fiber
oral consumption in beverage
|
|
Placebo beverage: Placebo Comparator
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| Contact: Carolyn Williams, RD, LD | 502.214.3970 | cwilliams@lmarc.com |
| Contact: Joy Frestedt, PhD | 952.922.2329 | jf@frestedt.com |
| United States, Kentucky | |
| Louisville Metabolic and Atherosclerosis Research Center (LMARC) | Recruiting |
| Louisville, Kentucky, United States, 40213 | |
| Contact: Brian Dawson, RN, BSN 502-214-3990 bdawson@lmarc.com | |
| Contact: Joy Frestedt, PhD 952.922.2329 jf@frestedt.com | |
| Principal Investigator: Harold E Bays, MD, FACP | |
| Sub-Investigator: Frank Walker, MD | |
| Principal Investigator: | Harold E Bays, MD, FACP | Louisville Metabolic and Atherosclerosis Research Center |
More Information
| Responsible Party: | Louisville Metabolic and Atherosclerosis Research Center (LMARC) ( Harold E. Bays, MD, FACP/ Medical Director and President ) |
| Study ID Numbers: | CFIS-08-003 |
| Study First Received: | January 8, 2009 |
| Last Updated: | January 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00820807 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
dietary fiber fiber insulin sensitivity insulin resistance glucose metabolism |
|
Hyperinsulinism Metabolic Diseases Insulin Resistance Glucose Metabolism Disorders |