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NCT01698112 · ClinicalTrials.gov registry record · NA
Does Flaxseed Supplementation Improve Glycemic Control in Individuals With Pre-diabetes?
A NA study, sponsored by University of Colorado, Colorado Springs.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT01698112 is a NA study that has completed, run by University of Colorado, Colorado Springs. The registered enrollment target is 25 participants.
The verdict
NCT01698112, a NA study, has completed, sponsored by University of Colorado, Colorado Springs.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
This project is a clinical intervention trial that will determine the role of a functional food, flaxseed, on the control of blood glucose levels in people with pre-diabetes. People with pre-diabetes have high blood glucose levels since their cells do not respond to insulin as they should. Over time, people with pre-diabetes may progress to type 2 diabetes and have increased risk for heart and kidney diseases. Although the long-term complications associated with type 2 diabetes are well-recognized, clinicians and researchers are now realizing that some long-term damage to the body, especially the heart and circulatory system, may already be occurring during pre-diabetes. Consequently, clinicians are recognizing that glucose control, through diet, exercise and, if necessary, medications, is as important for people with pre-diabetes as it is for people with type 2 diabetes. Standard treatments for pre-diabetes are glucose control through diet, exercise, and drugs. A possible treatment that could be added to the standard treatments is intake of flaxseed. Few studies have looked at the effect of flaxseed intake on glucose control and those that have enrolled people with type 2 diabetes. To date, no studies have reported flaxseed's affect on controlling blood glucose in people with pre-diabetes. Therefore, more research is needed to determine if flaxseed is an effective means of controlling glucose levels in people with pre-diabetes. This study will help determine whether or not eating modest amounts of flaxseed every day will improve blood glucose and insulin levels in overweight or obese men and postmenopausal women with pre-diabetes. It will also show if flaxseed intake will reduce the degree of inflammation they are experiencing. If flaxseed consumption does help control blood glucose levels in people with pre-diabetes and reduce the degree of inflammation they are experiencing, it may help prevent or delay their progression to type 2 diabetes.
Interventions
- DIETARY_SUPPLEMENT Flaxseed High Dose
- DIETARY_SUPPLEMENT Flaxseed Low Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2006-07 |
| Est. Completion | 2009-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01698112
The ClinicalTrials.gov registry entry for NCT01698112 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Colorado Springs, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Flaxseed High Dose is the first listed.
NCT01698112 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01698112 about?
NCT01698112 is a clinical study titled "Does Flaxseed Supplementation Improve Glycemic Control in Individuals With Pre-diabetes?". This project is a clinical intervention trial that will determine the role of a functional food, flaxseed, on the control of blood glucose levels in people with pre-diabetes. People with pre-diabetes have high blood glucose levels since their cells do not respond to insulin as they should. Over time...
What is the current status of trial NCT01698112?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2006-07. Estimated completion is 2009-06.
What interventions are being tested in trial NCT01698112?
The interventions under investigation include: Flaxseed High Dose (DIETARY_SUPPLEMENT), Flaxseed Low Dose (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01698112?
This trial is sponsored by University of Colorado, Colorado Springs, which has 14 total clinical trials registered on ClinicalTrials.gov.
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