The Effects of Flaxseed Supplement on Weight and Biochemical Factors in Overweight and Obese Subject

Phase 2

Completed

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: flaxseed; Behavioral: Exercise recommendation

• Registration Number: NCT02410668
• Lead Sponsor: National Nutrition and Food Technology Institute

Brief Summary

To study the effects of Flaxseed supplement on weight, lipid profile and inflammatory factors in subjects with over weight and obesity, 50 patients will be randomly allocated to receive placebo or 30 grams milled Flaxseed for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, weight, waist and hip circumference, lipid profile and some inflammatory markers will be assessed and compared between groups.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-03
• Primary Completion: 2014-08
• Study Completion: 2015-01
• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-06
• Last Update Submitted: 2015-04-06
• Study First Posted: 2015-04-07
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age of 18 to 70 years
• Body Mass Index (BMI) between 25-40

Exclusion Criteria

• diabetes mellitus
• cardiovascular diseases and cancers
• major systemic diseases
• gastrointestinal problems
• liver and renal failure
• history of allergy or high consumption of nuts, flaxseed, or sesame seeds
• weight loss within the past 6 mo of >5% of body weight or current adherence to a weight-reduction diet
• pregnancy, lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flaxseed	Exercise recommendation	30 grams Flaxseed powder combine with dietary and exercise recommendation
control	Exercise recommendation	dietary and exercise recommendation
control	Placebo	dietary and exercise recommendation
Flaxseed	flaxseed	30 grams Flaxseed powder combine with dietary and exercise recommendation

Primary Outcome Measures

Name	Time	Method
weight	12 weeks
waist and hip circumference	12 weeks

Secondary Outcome Measures

Name	Time	Method
lipid profile	12 weeks