Metabolic Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTflaxseed
BEHAVIORALlifestyle modification
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance index (HOMA-IR) | 12 weeks | The homeostatic model assessment (HOMA) |
Outcome results
None listed