Does Flaxseed Supplementation Improve Glycemic Control in Individuals With Pre-diabetes?

PreDiabetes Clinical Trial

Official title: Does Flaxseed Supplementation Improve Glycemic Control in Individuals With Pre-diabetes?

Status Completed

Clinical Trial 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.

Clinical Trial Description

Pre-diabetes is characterized by hyperglycemia due to ineffective insulin or 'insulin resistance'. Over time, people with pre-diabetes may progress to type 2 diabetes and experience complications including cardiovascular and peripheral vascular disease, hyperlipidemia, retinopathy, neuropathy, and/or nephropathy. Conventional interventions for pre-diabetes are glucose control through diet, exercise, and, if necessary, medications. An efficient but still uncommon adjunct intervention is flaxseed supplementation. Since few studies have examined the affect of flaxseed supplementation on type 2 diabetes and to date, no studies have reported flaxseed's influence on glycemic control in individuals with pre-diabetes, additional research is warranted. The objective of this study is to determine the affect of consuming flaxseed on fasting plasma glucose, insulin, fructosamine, adiponectin, fatty acid concentrations, serum interleukin-6 (hs-IL-6), C-reactive protein (hs-CRP), and urinary lignan excretion in overweight or obese men and postmenopausal women with pre-diabetes. This research will provide data for the strength of the relationship between regular flaxseed intake and biomarkers for pre-diabetes and glycemic control as well as adiponectin values and markers of inflammation. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• PreDiabetes

• NCT number: NCT01698112
• Study type: Interventional
• Source: University of Colorado, Colorado Springs
• Status: Completed
• Phase: N/A
• Start date: July 2006
• Completion date: June 2009