PreDiabetesNCT01698112
Does Flaxseed Supplementation Improve Glycemic Control in Individuals With Pre-diabetes?
A study testing Flaxseed High Dose and Flaxseed Low Dose in people with PreDiabetes, run by University of Colorado, Colorado Springs at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Flaxseed High Dose and Flaxseed Low Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2006to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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;
Show all 9Show fewer
- (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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Colorado Springs
Colorado Springs, Colorado, 80918
University of Montana
Missoula, Montana, 59812
About this study
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.
Read more
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.
Read the 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.
- Conditions
- PreDiabetes
- Being tested
- Flaxseed High Dose, Flaxseed Low Dose
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flaxseed High DoseDietary supplement
26 gram flaxseed intervention
Flaxseed Low DoseDietary supplement
13 grams flaxseed
| Study group | Role | What they receive |
|---|---|---|
| Flaxseed High Dose | Experimental | Not described Receives: Dietary Supplement: Flaxseed High Dose |
| Flaxseed Low Dose | Experimental | Not described Receives: Dietary Supplement: Flaxseed Low Dose |
| Flaxseed control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose
Measured: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
Fasting insulin
Measured: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
Fasting fructosamine
Measured: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
Secondary outcomes (3)
C-reactive protein
Measured: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
interleukin 6
Measured: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
adiponectin
Measured: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startJul 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Colorado Springs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Hutchins, University of Colorado, Colorado Springs
- Investigators
- Andrea Hutchins, PhD, Principal investigator, University of Colorado, Colorado Springs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698112
- Sponsor's protocol ID
- PreDiabetes Flax
- Other IDs
- 7-06-RA-61
- Status last verified
- Sep 2012
- First submitted
- 25 Sep 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Flaxseed Supplementation Improve Glycemic Control in Individuals With Pre-diabetes?
- ClinicalTrials.gov ID
- NCT01698112
- Acronym / sponsor ID
- PreDiabetes Flax
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Colorado, Colorado SpringsUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flaxseed High Dose | Experimental | Dietary Supplement: Flaxseed High Dose |
| Flaxseed Low Dose | Experimental | Dietary Supplement: Flaxseed Low Dose |
| Flaxseed control | No intervention | – |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- (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;
Key exclusion criteria (9 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flaxseed High Dose26 gram flaxseed intervention | Dietary supplement | Flaxseed High Dose |
| Flaxseed Low Dose13 grams flaxseed | Dietary supplement | Flaxseed Low Dose |
Primary outcome
Fasting glucose
Time frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
Fasting insulin
Time frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
Fasting fructosamine
Time frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
3 secondary outcomes
C-reactive protein
Time frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
interleukin 6
Time frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
adiponectin
Time frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Hutchins, PhD principal investigator
University of Colorado, Colorado Springs
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flaxseed High Dose and Flaxseed Low Dose in people with PreDiabetes, run by University of Colorado, Colorado Springs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose (time frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012.