- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01698112
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, 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80918
- University of Colorado Colorado Springs
-
-
Montana
-
Missoula, Montana, United States, 59812
- University of Montana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- (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.
Exclusion Criteria:
- (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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Flaxseed High Dose
|
26 gram flaxseed intervention
|
Experimental: Flaxseed Low Dose
|
13 grams flaxseed
|
No Intervention: Flaxseed control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fasting glucose
Time Frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
|
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)
|
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)
|
beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
C-reactive protein
Time Frame: beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
|
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)
|
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)
|
beginning and end of each 12-week intervention (start of 1st week and end of 12th week)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andrea Hutchins, PhD, University of Colorado, Colorado Springs
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PreDiabetes Flax
- 7-06-RA-61 (Other Grant/Funding Number: American Diabetes Association/7-06-RA-61)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on PreDiabetes
-
Aga Khan UniversityLinnaeus University; Kenyatta UniversityRecruiting
-
Philip KernNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting
-
Chonbuk National University HospitalCompletedPreDiabetes
-
TNOWageningen University and Research; Google LLC.; Jumbo Supermarkten Bv.; Noldus...Completed
-
University of TorontoInternational Nut and Dried Fruit Council (INC); The National Dried Fruit Trade... and other collaboratorsUnknown
-
National Yang Ming UniversityRecruiting
-
Albert Einstein College of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Clinical Nutrition Research Centre, SingaporeSingapore Institute for Clinical SciencesCompleted
-
Northwestern UniversityAllianceChicago; Erie Family Health CentersCompleted
-
Ohio UniversityTouro University, CaliforniaCompletedPreDiabetes
Clinical Trials on Flaxseed High Dose
-
Beijing Northland Biotech. Co., Ltd.CompletedAcute Myocardial InfarctionChina
-
National Institute of Diabetes and Digestive and...Washington University School of Medicine; University of Alabama at Birmingham; Icahn School of Medicine at Mount Sinai and other collaboratorsCompletedEnd Stage Renal DiseaseUnited States
-
MedImmune LLCCompletedNon-alcoholic Fatty Liver Disease (NAFLD) | Non-alcoholic Steatohepatitis (NASH)United States, Puerto Rico
-
Beijing Northland Biotech. Co., Ltd.CompletedSafety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.InfarctionAcute Myocardial InfarctionChina
-
Baylor College of MedicineNeuroMetrix, Inc.RecruitingPain | Neuropathy | Chemotherapy-induced Peripheral NeuropathyUnited States
-
University of British ColumbiaFlax Council of CanadaTerminatedPostprandial LipaemiaCanada
-
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate...RecruitingSystemic Lupus ErythematosusUnited States, Spain, China, Korea, Republic of, Argentina, Bulgaria, Chile, Greece, Japan, Mauritius, Mexico, Moldova, Republic of, Poland, South Africa, Australia, Colombia, Philippines, Serbia
-
Jiangsu Kanion Pharmaceutical Co., LtdCompleted
-
Purdue UniversityAlliance for Potato Research and EducationCompletedBlood Pressure | Potassium BioavailabilityUnited States
-
University of California, San FranciscoNot yet recruitingProstate Adenocarcinoma | Localized Prostate CarcinomaUnited States