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

Overweight and Obesity Clinical Trial

Official title:

The Effects of Flaxseed Supplement on Weight, Lipid Profile and Inflammatory Factors in Overweight and Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410668
• Other study ID #: 1368
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 2, 2015
• Last updated: April 6, 2015
• Start date: March 2014
• Est. completion date: January 2015

Study information

• Verified date: March 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• flaxseed

• Placebo

Behavioral:
• Exercise recommendation

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	weight		12 weeks	Yes
Primary	waist and hip circumference		12 weeks	Yes
Secondary	lipid profile		12 weeks	Yes