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

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ClinicalTrials.gov Identifier: NCT01549626
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : March 9, 2012
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adult Women Overweight Obese Dietary Supplement: Defatted flaxseed flour Dietary Supplement: Golden flaxseed flour Dietary Supplement: Whole brown flaxseed flour Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : March 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2012
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: defatted flaxseed flour
30 grams per day of defatted 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
Active Comparator: golden flaxseed flour
30 grams per day of golden flaxseed flour
 Dietary Supplement: Defatted flaxseed flour
30g defatted flaxseed flour per day for breakfast
Other Names:
  • Golden 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
Active Comparator: whole brown flaxseed flour
30 grams per day of whole brown flaxseed flour
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult women

Exclusion Criteria:

  • women diabetic
  • menopausal
  • smokers
  • pregnant
  • using anorectic and satiogenic drugs
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549626


Locations
Brazil
Clementino Fraga Filho University Hospital
Rio de Janeiro, Brazil, 21.941-913
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Wania Lucia Araujo Monteiro, Nutritionist, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01549626     History of Changes
Other Study ID Numbers: w831102m
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

Keywords provided by Wania Lucia Araujo Monteiro, Federal University of Rio de Janeiro:
Flaxseed
Women
Obesity
No smokers

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms