- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01549626
Effects of Flaxseed Flour in Appetite Sensations, Lipid Profile and Pressure Levels Among Overweighed and Obese Women
March 8, 2012 updated by: Wania Lucia Araujo Monteiro, Universidade Federal do Rio de Janeiro
Effects of Flaxseed Flour - Whole Brown Flaxseed Flour, Brown Defatted Flaxseed Flour and Golden Flaxseed Flour in Appetite Sensations Satiety, Lipid Profile, Pressure Levels and Associated Costs Among Overweighed and Obese Women
Inclusion of foods rich in fiber, such as flaxseed, is a nutritional strategy for treating obesity.
The hypothesis of this study is to compare the effects of three types of flaxseed flour - whole brown flaxseed flour, brown defatted flaxseed flour and golden flaxseed flour in the sensations of appetite and satiety, lipid profile, pressure levels and associated costs in overweight and obese women.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rio de Janeiro, Brazil, 21.941-913
- Clementino Fraga Filho University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- adult women
Exclusion Criteria:
- women diabetic
- menopausal
- smokers
- pregnant
- using anorectic and satiogenic drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: defatted flaxseed flour
30 grams per day of defatted flaxseed flour
|
30 grams of golden flaxseed flour per day for breakfast
Other Names:
30 grams of whole brown flaxseed flour per day for breakfast
Other Names:
|
Active Comparator: golden flaxseed flour
30 grams per day of golden flaxseed flour
|
30 grams of whole brown flaxseed flour per day for breakfast
Other Names:
30g defatted flaxseed flour per day for breakfast
Other Names:
|
Active Comparator: whole brown flaxseed flour
30 grams per day of whole brown flaxseed flour
|
30 grams of golden flaxseed flour per day for breakfast
Other Names:
30g defatted flaxseed flour per day for breakfast
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appetite
Time Frame: Up to 2 months
|
Compare the effects of three different types of flaxseed flour - whole brown flaxseed flour (WBFF), brown defatted flaxseed flour (BDFF), and golden flaxseed flour (GFF) - in subjective sensations of appetite in overweighed and obese women.
|
Up to 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satiety
Time Frame: Up to 2 months
|
Compare the effects of three different types of flaxseed flour - whole brown flaxseed flour (WBFF), brown defatted flaxseed flour (BDFF), and golden flaxseed flour (GFF) - in subjective sensations of satiety in overweighed and obese women.
|
Up to 2 months
|
LDL-cholesterol
Time Frame: Up to 2 months
|
Compare the effects of three different types of flaxseed flour - whole brown flaxseed flour (WBFF), brown defatted flaxseed flour (BDFF) and golden flaxseed flour (GFF) - in reducing cardiovascular risk factors in overweighed and obese women.
|
Up to 2 months
|
HDL-cholesterol
Time Frame: Up to 2 months
|
Compare the effects of three different types of flaxseed flour - whole brown flaxseed flour (WBFF), brown defatted flaxseed flour (BDFF) and golden flaxseed flour (GFF) - in reducing cardiovascular risk factors in overweighed and obese women.
|
Up to 2 months
|
Total Cholesterol
Time Frame: Up to 2 months
|
Compare the effects of three different types of flaxseed flour - whole brown flaxseed flour (WBFF), brown defatted flaxseed flour (BDFF) and golden flaxseed flour (GFF) - in reducing cardiovascular risk factors in overweighed and obese women.
|
Up to 2 months
|
Triglycerides
Time Frame: Up to 2 months
|
Compare the effects of three different types of flaxseed flour - whole brown flaxseed flour (WBFF), brown defatted flaxseed flour (BDFF) and golden flaxseed flour (GFF) - in reducing cardiovascular risk factors in overweighed and obese women.
|
Up to 2 months
|
Glucose
Time Frame: Up to 2 months
|
Compare the effects of three different types of flaxseed flour - whole brown flaxseed flour (WBFF), brown defatted flaxseed flour (BDFF) and golden flaxseed flour (GFF) - in reducing cardiovascular risk factors in overweighed and obese women.
|
Up to 2 months
|
Uric acid
Time Frame: Up to 2 months
|
Compare the effects of three different types of flaxseed flour - whole brown flaxseed flour (WBFF), brown defatted flaxseed flour (BDFF) and golden flaxseed flour (GFF) - in reducing cardiovascular risk factors in overweighed and obese women.
|
Up to 2 months
|
Systemic blood pressure
Time Frame: Up to 2 months
|
Compare the effects of three different types of flaxseed flour - whole brown flaxseed flour (WBFF), brown defatted flaxseed flour (BDFF) and golden flaxseed flour (GFF) - in reducing cardiovascular risk factors in overweighed and obese women.
|
Up to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
February 28, 2012
First Submitted That Met QC Criteria
March 8, 2012
First Posted (Estimate)
March 9, 2012
Study Record Updates
Last Update Posted (Estimate)
March 9, 2012
Last Update Submitted That Met QC Criteria
March 8, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- w831102m
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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