Effects of Flaxseed Supplementation in Metabolic Syndrome
July 13, 2015 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
To evaluate the effects of flaxseed supplementation on fasting blood sugar, lipid profile and anthropocentric measurements in subjects with metabolic syndrome, in a randomized, open-labeled, controlled pilot study, 44 subjects with metabolic syndrome will be received 30g/d flaxseed with lifestyle modification or lifestyle modification alone for 12 weeks.
Both groups will be advised to follow an energy balanced diet and physical activity recommendations.
Parameters related to metabolic syndrome will be measured at the baseline and at the end of the study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age and older
- having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report
Exclusion Criteria:
- history of allergy or high consumption of nuts, flaxseed, or sesame seeds
- clinically diagnosed renal, liver, heart, pituitary, thyroid, or psychiatric disorders impairing the patient's ability to provide written informed consent
- history of cardiovascular diseases, cancers, alimentary tract disorders affecting absorption
- pregnancy, lactation, and lack of effective birth control in women of child-bearing potential
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Flaxseed
30 g milled brown flaxseed + lifestyle modification
|
|
|
Active Comparator: control
lifestyle modification including dietary and physical activity recommendation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin resistance index (HOMA-IR)
Time Frame: 12 weeks
|
The homeostatic model assessment (HOMA)
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
July 10, 2015
First Submitted That Met QC Criteria
July 13, 2015
First Posted (Estimate)
July 14, 2015
Study Record Updates
Last Update Posted (Estimate)
July 14, 2015
Last Update Submitted That Met QC Criteria
July 13, 2015
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 765
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.