NCT02497352

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
Last Updated

July 14, 2015

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

July 10, 2015

Last Update Submit

July 13, 2015

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Insulin resistance index (HOMA-IR)

    The homeostatic model assessment (HOMA)

    12 weeks

Study Arms (2)

Flaxseed

EXPERIMENTAL

30 g milled brown flaxseed + lifestyle modification

Dietary Supplement: flaxseedBehavioral: lifestyle modification

control

ACTIVE COMPARATOR

lifestyle modification including dietary and physical activity recommendation

Behavioral: lifestyle modification

Interventions

flaxseedDIETARY_SUPPLEMENT
Flaxseed
lifestyle modificationBEHAVIORAL
Flaxseedcontrol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 10, 2015

First Posted

July 14, 2015

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Last Updated

July 14, 2015

Record last verified: 2014-12