Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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
  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 Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.
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:
  • 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

  Eligibility
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Universidade Federal do Rio de Janeiro:
Flaxseed
Women
Obesity
No smokers

ClinicalTrials.gov processed this record on February 27, 2015