Effects of Flaxseed Supplementation in Metabolic Syndrome
Phase 2
Completed
- Conditions
- Metabolic Syndrome
- Registration Number
- NCT02497352
- Lead Sponsor
- National Nutrition and Food Technology Institute
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Insulin resistance index (HOMA-IR) 12 weeks The homeostatic model assessment (HOMA)
- Secondary Outcome Measures
Name Time Method