Effects of Flaxseed Supplementation in Metabolic Syndrome

Phase 2

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: flaxseed; Behavioral: lifestyle modification

• 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

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-08
• Status Verified: 2014-12
• Study First Submitted: 2015-07-10
• Study First Submitted QC: 2015-07-13
• Last Update Submitted: 2015-07-13
• Study First Posted: 2015-07-14
• Last Update Posted: 2015-07-14

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

Arm && Interventions

Group	Intervention	Description
Flaxseed	flaxseed	30 g milled brown flaxseed + lifestyle modification
Flaxseed	lifestyle modification	30 g milled brown flaxseed + lifestyle modification
control	lifestyle modification	lifestyle modification including dietary and physical activity recommendation

Primary Outcome Measures

Name	Time	Method
Insulin resistance index (HOMA-IR)	12 weeks	The homeostatic model assessment (HOMA)