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Effects of Flaxseed Flour in Appetite Sensations, Lipid Profile and Pressure Levels Among Overweighed and Obese Women
This study has been completed.
Sponsor:
Universidade Federal do Rio de Janeiro
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
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Purpose
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 | Intervention |
|---|---|
| Adult Women Overweight Obese | Dietary Supplement: Defatted flaxseed flour Dietary Supplement: Golden flaxseed flour Dietary Supplement: Whole brown flaxseed flour |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: 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 |
Further study details as provided by Wania Lucia Araujo Monteiro, Federal University of Rio de Janeiro:
Primary Outcome Measures:
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
| Enrollment: | 54 |
| Study Start Date: | March 2009 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
Dietary Supplement: Whole brown flaxseed flour
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
|
Dietary Supplement: Defatted flaxseed flour
30g defatted flaxseed flour per day for breakfast
Other Names:
Dietary Supplement: Whole brown flaxseed flour
30 grams of whole brown flaxseed flour per day for breakfast
Other Names:
|
|
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:
Dietary Supplement: Golden flaxseed flour
30 grams of golden flaxseed flour per day for breakfast
Other Names:
|
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01549626
Please refer to this study by its ClinicalTrials.gov identifier: 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
| 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 |
| Study First Received: | February 28, 2012 |
| Last Updated: | March 8, 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 |
ClinicalTrials.gov processed this record on July 19, 2017