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

Overweight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549626
• Other study ID #: w831102m
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: March 8, 2012
• Start date: March 2009
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• adult women

Exclusion Criteria:

• women diabetic

• menopausal

• smokers

• pregnant

• using anorectic and satiogenic drugs

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adult Women
• Obese
• Overweight

Intervention

Dietary Supplement:
• Defatted flaxseed flour
30g defatted flaxseed flour per day for breakfast
• Golden flaxseed flour
30 grams of golden flaxseed flour per day for breakfast
• Whole brown flaxseed flour
30 grams of whole brown flaxseed flour per day for breakfast

Locations

Country	Name	City	State
Brazil	Clementino Fraga Filho University Hospital	Rio de Janeiro

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 2 months	No
Secondary	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.	Up to 2 months	No
Secondary	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.	Up to 2 months	No
Secondary	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.	Up to 2 months	No
Secondary	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.	Up to 2 months	No
Secondary	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.	Up to 2 months	No
Secondary	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.	Up to 2 months	No
Secondary	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.	Up to 2 months	No
Secondary	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.	Up to 2 months	No