Effects of Flaxseed Supplementation in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497352
• Other study ID #: 765
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 10, 2015
• Last updated: July 13, 2015
• Start date: February 2014

Study information

• Verified date: December 2014
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: IRAN: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Dietary Supplement:
• flaxseed

Behavioral:
• lifestyle modification

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance index (HOMA-IR)	The homeostatic model assessment (HOMA)	12 weeks	No