The Effects of Flaxseed Supplement on Weight and Biochemical Factors in Overweight and Obese Subject
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2014
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 2, 2015
CompletedFirst Posted
Study publicly available on registry
April 7, 2015
CompletedApril 7, 2015
March 1, 2014
5 months
April 2, 2015
April 6, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
weight
12 weeks
waist and hip circumference
12 weeks
Secondary Outcomes (1)
lipid profile
12 weeks
Study Arms (2)
Flaxseed
ACTIVE COMPARATOR30 grams Flaxseed powder combine with dietary and exercise recommendation
control
PLACEBO COMPARATORdietary and exercise recommendation
Interventions
Eligibility Criteria
You may qualify if:
- Age of 18 to 70 years
- Body Mass Index (BMI) between 25-40
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Yari Z, Rahimlou M, Poustchi H, Hekmatdoost A. Flaxseed supplementation improves anthropometric measurements, metabolic, and inflammatory biomarkers in overweight and obese adults. Int J Vitam Nutr Res. 2022 Jul;92(3-4):161-168. doi: 10.1024/0300-9831/a000565. Epub 2019 Mar 7.
PMID: 30843767DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 2, 2015
First Posted
April 7, 2015
Study Start
March 1, 2014
Primary Completion
August 1, 2014
Study Completion
January 1, 2015
Last Updated
April 7, 2015
Record last verified: 2014-03