Effects of Flaxseed Supplementation in Metabolic Syndrome

NCT ID: NCT02497352

Last Updated: 2015-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Flaxseed

30 g milled brown flaxseed + lifestyle modification

Group Type EXPERIMENTAL

flaxseed

Intervention Type DIETARY_SUPPLEMENT

lifestyle modification

Intervention Type BEHAVIORAL

control

lifestyle modification including dietary and physical activity recommendation

Group Type ACTIVE_COMPARATOR

lifestyle modification

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

flaxseed

Intervention Type DIETARY_SUPPLEMENT

lifestyle modification

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Azita Hekmatdoost

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

765

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Flaxseed Mucilage and Satiety
NCT01238744 UNKNOWN NA
Flaxseed for the Treatment of Hot Flashes
NCT00275704 COMPLETED PHASE2
Flax Muffins and Cholesterol Lowering
NCT01821131 ACTIVE_NOT_RECRUITING NA
Flax Lignans and Heart Health
NCT01314586 COMPLETED NA