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

Intervention / Treatment

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

  • Brazil
      • 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
Dietary supplement: Golden flaxseed flour
30 grams of golden flaxseed flour per day for breakfast
Other Names:
  • Whole brown flaxseed flour
  • Defatted flaxseed flour
Dietary supplement: Whole brown flaxseed flour
30 grams of whole brown flaxseed flour per day for breakfast
Other Names:
  • Golden flaxseed flour
  • Defatted flaxseed flour
Active Comparator: golden flaxseed flour
30 grams per day of golden flaxseed flour
Dietary supplement: Whole brown flaxseed flour
30 grams of whole brown flaxseed flour per day for breakfast
Other Names:
  • Golden flaxseed flour
  • Defatted flaxseed flour
Dietary supplement: Defatted flaxseed flour
30g defatted flaxseed flour per day for breakfast
Other Names:
  • Golden flaxseed flour
  • Whole brown flaxseed flour
Active Comparator: whole brown flaxseed flour
30 grams per day of whole brown flaxseed flour
Dietary supplement: Golden flaxseed flour
30 grams of golden flaxseed flour per day for breakfast
Other Names:
  • Whole brown flaxseed flour
  • Defatted flaxseed flour
Dietary supplement: Defatted flaxseed flour
30g defatted flaxseed flour per day for breakfast
Other Names:
  • Golden flaxseed flour
  • Whole brown flaxseed flour

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.

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)

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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