Effects of Flaxseed Supplementation in Metabolic Syndrome

National Nutrition and Food Technology Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Metabolic Syndrome

Treatments: Behavioral: lifestyle modification; Dietary Supplement: flaxseed

Study type: Interventional

Funder types: Other

Identifiers

NCT02497352

765

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Flaxseed

Experimental group

Description:

30 g milled brown flaxseed + lifestyle modification

Treatment:

Dietary Supplement: flaxseed

Behavioral: lifestyle modification

control

Active Comparator group

Description:

lifestyle modification including dietary and physical activity recommendation

Treatment:

Behavioral: lifestyle modification