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Completed

NCT Number: NCT02410668

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flaxseed

Dietary Supplement

Placebo

Dietary Supplement

Exercise recommendation

Behavioral

Primary outcomes

  1. weight

    Time frame: 12 weeks

  2. waist and hip circumference

    Time frame: 12 weeks

Secondary outcomes

  1. lipid profile

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Apr 7, 2015
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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