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

NCT ID: NCT01698112

Last Updated: 2012-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-06-30

Brief Summary

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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

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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

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PreDiabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flaxseed High Dose

Group Type EXPERIMENTAL

Flaxseed High Dose

Intervention Type DIETARY_SUPPLEMENT

26 gram flaxseed intervention

Flaxseed Low Dose

Group Type EXPERIMENTAL

Flaxseed Low Dose

Intervention Type DIETARY_SUPPLEMENT

13 grams flaxseed

Flaxseed control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Flaxseed High Dose

26 gram flaxseed intervention

Intervention Type DIETARY_SUPPLEMENT

Flaxseed Low Dose

13 grams flaxseed

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Colorado Springs

OTHER

Sponsor Role lead

Responsible Party

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Andrea Hutchins

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Hutchins, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Colorado Springs

Locations

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University of Colorado Colorado Springs

Colorado Springs, Colorado, United States

Site Status

University of Montana

Missoula, Montana, United States

Site Status

Countries

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United States

Other Identifiers

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7-06-RA-61

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PreDiabetes Flax

Identifier Type: -

Identifier Source: org_study_id