Does Flaxseed Supplementation Improve Glycemic Control in Individuals With Pre-diabetes?
Condition: PreDiabetes
MeSH terms: Prediabetic State
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Flaxseed High Dose; Flaxseed Low Dose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 26 gram flaxseed intervention; 13 grams flaxseed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment