Effects of Flaxseed Flour in Appetite Sensations, Lipid Profile and Pressure Levels Among Overweighed and Obese Women

This study has been completed.

Sponsor:

Collaborators:

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Information provided by (Responsible Party):

Wania Lucia Araujo Monteiro, Federal University of Rio de Janeiro

ClinicalTrials.gov Identifier:

NCT01549626

First received: February 28, 2012

Last updated: March 8, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 28, 2012
Last Updated Date	March 8, 2012
Start Date ^ICMJE	March 2009
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 8, 2012)	Appetite [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01549626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 8, 2012)	Satiety [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ] 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. LDL-cholesterol [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ] 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. HDL-cholesterol [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ] 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. Total Cholesterol [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ] 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. Triglycerides [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ] 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. Glucose [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ] 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. Uric acid [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ] 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. Systemic blood pressure [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Flaxseed Flour in Appetite Sensations, Lipid Profile and Pressure Levels Among Overweighed and Obese Women
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Adult Women Overweight Obese
Intervention ^ICMJE	Dietary Supplement: Defatted flaxseed flour 30g defatted flaxseed flour per day for breakfast Other Names: Golden flaxseed flour Whole brown flaxseed flour Dietary Supplement: Golden flaxseed flour 30 grams of golden flaxseed flour per day for breakfast Other Names: Defatted flaxseed flour Whole brown flaxseed flour Dietary Supplement: Whole brown flaxseed flour 30 grams of whole brown flaxseed flour per day for breakfast Other Names: Defatted flaxseed flour Golden flaxseed flour
Study Arm (s)	Active Comparator: defatted flaxseed flour 30 grams per day of defatted flaxseed flour Interventions: Dietary Supplement: Golden flaxseed flour Dietary Supplement: Whole brown flaxseed flour Active Comparator: golden flaxseed flour 30 grams per day of golden flaxseed flour Interventions: Dietary Supplement: Defatted flaxseed flour Dietary Supplement: Whole brown flaxseed flour Active Comparator: whole brown flaxseed flour 30 grams per day of whole brown flaxseed flour Interventions: Dietary Supplement: Defatted flaxseed flour Dietary Supplement: Golden flaxseed flour
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	54
Completion Date	March 2012
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: adult women Exclusion Criteria: women diabetic menopausal smokers pregnant using anorectic and satiogenic drugs
Gender	Female
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01549626
Other Study ID Numbers ^ICMJE	w831102m
Has Data Monitoring Committee	Yes
Responsible Party	Wania Lucia Araujo Monteiro, Federal University of Rio de Janeiro
Study Sponsor ^ICMJE	Federal University of Rio de Janeiro
Collaborators ^ICMJE	Rio de Janeiro State Research Supporting Foundation (FAPERJ) Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators ^ICMJE	Not Provided
Information Provided By	Federal University of Rio de Janeiro
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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