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

Primary Purpose

Adult Women, Overweight, Obese

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Defatted flaxseed flour
Golden flaxseed flour
Whole brown flaxseed flour
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adult Women focused on measuring Flaxseed, Women, Obesity, No smokers

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • adult women

Exclusion Criteria:

  • women diabetic
  • menopausal
  • smokers
  • pregnant
  • using anorectic and satiogenic drugs

Sites / Locations

  • Clementino Fraga Filho University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

defatted flaxseed flour

golden flaxseed flour

whole brown flaxseed flour

Arm Description

30 grams per day of defatted flaxseed flour

30 grams per day of golden flaxseed flour

30 grams per day of whole brown flaxseed flour

Outcomes

Primary Outcome Measures

Appetite
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
February 28, 2012
Last Updated
March 8, 2012
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01549626
Brief Title
Effects of Flaxseed Flour in Appetite Sensations, Lipid Profile and Pressure Levels Among Overweighed and Obese Women
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 Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Women, Overweight, Obese
Keywords
Flaxseed, Women, Obesity, No smokers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
defatted flaxseed flour
Arm Type
Active Comparator
Arm Description
30 grams per day of defatted flaxseed flour
Arm Title
golden flaxseed flour
Arm Type
Active Comparator
Arm Description
30 grams per day of golden flaxseed flour
Arm Title
whole brown flaxseed flour
Arm Type
Active Comparator
Arm Description
30 grams per day of whole brown flaxseed flour
Intervention Type
Dietary Supplement
Intervention Name(s)
Defatted flaxseed flour
Other Intervention Name(s)
Golden flaxseed flour, Whole brown flaxseed flour
Intervention Description
30g defatted flaxseed flour per day for breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
Golden flaxseed flour
Other Intervention Name(s)
Defatted flaxseed flour, Whole brown flaxseed flour
Intervention Description
30 grams of golden flaxseed flour per day for breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
Whole brown flaxseed flour
Other Intervention Name(s)
Defatted flaxseed flour, Golden flaxseed flour
Intervention Description
30 grams of whole brown flaxseed flour per day for breakfast
Primary Outcome Measure Information:
Title
Appetite
Description
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.
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Satiety
Description
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.
Time Frame
Up to 2 months
Title
LDL-cholesterol
Description
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.
Time Frame
Up to 2 months
Title
HDL-cholesterol
Description
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.
Time Frame
Up to 2 months
Title
Total Cholesterol
Description
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.
Time Frame
Up to 2 months
Title
Triglycerides
Description
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.
Time Frame
Up to 2 months
Title
Glucose
Description
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.
Time Frame
Up to 2 months
Title
Uric acid
Description
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.
Time Frame
Up to 2 months
Title
Systemic blood pressure
Description
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.
Time Frame
Up to 2 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adult women Exclusion Criteria: women diabetic menopausal smokers pregnant using anorectic and satiogenic drugs
Facility Information:
Facility Name
Clementino Fraga Filho University Hospital
City
Rio de Janeiro
ZIP/Postal Code
21.941-913
Country
Brazil

12. IPD Sharing Statement

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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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