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

National Nutrition and Food Technology Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: flaxseed; Behavioral: Exercise recommendation; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02410668

1368

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Flaxseed

Active Comparator group

Description:

30 grams Flaxseed powder combine with dietary and exercise recommendation

Treatment:

Dietary Supplement: flaxseed

Behavioral: Exercise recommendation

control

Placebo Comparator group

Description:

dietary and exercise recommendation

Treatment:

Behavioral: Exercise recommendation

Dietary Supplement: Placebo