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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Notify MeKey information
Conditions
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
Placebo
Dietary SupplementExercise recommendation
BehavioralPrimary outcomes
-
weight
Time frame: 12 weeks
-
waist and hip circumference
Time frame: 12 weeks
Secondary outcomes
-
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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