Does Flaxseed Supplementation Improve Glycemic Control in Individuals With Pre-diabetes?
2 other identifiers
interventional
25
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2006
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 25, 2012
CompletedFirst Posted
Study publicly available on registry
October 2, 2012
CompletedOctober 2, 2012
September 1, 2012
2.9 years
September 25, 2012
September 27, 2012
Conditions
Outcome Measures
Primary Outcomes (3)
Fasting glucose
beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
Fasting insulin
beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
Fasting fructosamine
beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
Secondary Outcomes (3)
C-reactive protein
beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
interleukin 6
beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
adiponectin
beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
Study Arms (3)
Flaxseed High Dose
EXPERIMENTALFlaxseed Low Dose
EXPERIMENTALFlaxseed control
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- (1) no unresolved health conditions (e.g. if high blood pressure is present it is under control due to diet and/or medications) and no diagnosis of type 2 diabetes;
- (2) non-smoking status;
- (3) no regular history of flaxseed or flaxseed oil supplement or fish oil supplement intake;
- (4) no regular history of sunflower seed intake (1/8 cup \< 1 time per week); fish intake (\< 12 ounces of fish/week); and soy intake (1 serving of soy \< 3 times per week; 1 serving of soy equals 3 oz. tofu, 8 oz. soy milk, ¼ c. soy nuts or ½ c. edamame);
- (5) willingness to follow study protocol, scheduling, and testing location;
- (6) body mass index (BMI) of 25-34.9 kg/m2;
- (7) men or postmenopausal women (no menstrual cycle for \> 6 months; women who have had a hysterectomy are eligible for participation) ages 50-65 years;
- (8) fasting glucose value of \> 100 and \< 126 mg/dL.
You may not qualify if:
- (1) unresolved health conditions or diagnosis of type 2 diabetes;
- (2) smokes;
- (3) regular history of flaxseed or flaxseed oil supplement or fish oil supplement intake;
- (4) regular history of sunflower seed intake (1/8 cup \< 1 time per week); fish intake (\< 12 ounces of fish/week); and soy intake (1 serving of soy \< 3 times per week; 1 serving of soy equals 3 oz. tofu, 8 oz. soy milk, ¼ c. soy nuts or ½ c. edamame);
- (5) unwillingness to follow study protocol, scheduling, and testing location;
- (6) body mass index (BMI) less than 25 or greater than 34.9 kg/m2;
- (7) premenopausal women;
- (8) men or postmenopausal women less than 50 or greater than 65 years of age;
- (9) fasting glucose value of less than 100 or greater than 126 mg/dL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Colorado Colorado Springs
Colorado Springs, Colorado, 80918, United States
University of Montana
Missoula, Montana, 59812, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Hutchins, PhD
University of Colorado, Colorado Springs
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 25, 2012
First Posted
October 2, 2012
Study Start
July 1, 2006
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
October 2, 2012
Record last verified: 2012-09