Adult WomenNCT01549626
Effects of Flaxseed Flour in Appetite Sensations, Lipid Profile and Pressure Levels Among Overweighed and Obese Women
A study testing Defatted flaxseed flour, Golden flaxseed flour and Whole brown flaxseed flour in people with Adult Women and Overweight, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adult Women, Overweight, Obese
- What is being tested?
- Defatted flaxseed flour, Golden flaxseed flour and Whole brown flaxseed flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- adult women
Who cannot join
- women diabetic
- menopausal
- smokers
- pregnant
- using anorectic and satiogenic drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clementino Fraga Filho University Hospital
Rio de Janeiro, Rio de Janeiro, 21.941-913
About this study
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
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.
- Conditions
- Adult Women, Overweight, Obese
- Being tested
- Defatted flaxseed flour, Golden flaxseed flour, Whole brown flaxseed flour
- Keywords
- Flaxseed, Women, Obesity, No smokers
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defatted flaxseed flourDietary supplement
Also called Golden flaxseed flour, Whole brown flaxseed flour
30g defatted flaxseed flour per day for breakfast
Golden flaxseed flourDietary supplement
Also called Defatted flaxseed flour, Whole brown flaxseed flour
30 grams of golden flaxseed flour per day for breakfast
Whole brown flaxseed flourDietary supplement
Also called Defatted flaxseed flour, Golden flaxseed flour
30 grams of whole brown flaxseed flour per day for breakfast
| Study group | Role | What they receive |
|---|---|---|
| defatted flaxseed flour | Active comparator | 30 grams per day of defatted flaxseed flour Receives: Dietary Supplement: Golden flaxseed flour; Dietary Supplement: Whole brown flaxseed flour |
| golden flaxseed flour | Active comparator | 30 grams per day of golden flaxseed flour Receives: Dietary Supplement: Defatted flaxseed flour; Dietary Supplement: Whole brown flaxseed flour |
| whole brown flaxseed flour | Active comparator | 30 grams per day of whole brown flaxseed flour Receives: Dietary Supplement: Defatted flaxseed flour; Dietary Supplement: Golden flaxseed flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 months
Secondary outcomes (8)
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.
Measured: Up to 2 months
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.
Measured: Up to 2 months
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.
Measured: Up to 2 months
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.
Measured: Up to 2 months
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.
Measured: Up to 2 months
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.
Measured: Up to 2 months
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.
Measured: Up to 2 months
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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startMar 2009
- Primary completionMar 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Wania Lucia Araujo Monteiro, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549626
- Sponsor's protocol ID
- w831102m
- Status last verified
- Mar 2012
- First submitted
- 28 Feb 2012
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01549626
- Acronym / sponsor ID
- w831102m
- Conditions
- Adult Women, Overweight, Obese
- Keywords
- Flaxseed, Women, Obesity, No smokers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Mar 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| defatted flaxseed flour | Active comparator | Dietary Supplement: Golden flaxseed flour, Dietary Supplement: Whole brown flaxseed flour30 grams per day of defatted flaxseed flour |
| golden flaxseed flour | Active comparator | Dietary Supplement: Defatted flaxseed flour, Dietary Supplement: Whole brown flaxseed flour30 grams per day of golden flaxseed flour |
| whole brown flaxseed flour | Active comparator | Dietary Supplement: Defatted flaxseed flour, Dietary Supplement: Golden flaxseed flour30 grams per day of whole brown flaxseed flour |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- adult women
Key exclusion criteria (5 listed)
- women diabetic
- menopausal
- smokers
- pregnant
- using anorectic and satiogenic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Defatted flaxseed flourAlso: Golden flaxseed flour, Whole brown flaxseed flour30g defatted flaxseed flour per day for breakfast | Dietary supplement | golden flaxseed flour, whole brown flaxseed flour |
| Golden flaxseed flourAlso: Defatted flaxseed flour, Whole brown flaxseed flour30 grams of golden flaxseed flour per day for breakfast | Dietary supplement | defatted flaxseed flour, whole brown flaxseed flour |
| Whole brown flaxseed flourAlso: Defatted flaxseed flour, Golden flaxseed flour30 grams of whole brown flaxseed flour per day for breakfast | Dietary supplement | defatted flaxseed flour, golden flaxseed flour |
Primary outcome
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.
8 secondary outcomes
Satiety
Time frame: Up to 2 months
LDL-cholesterol
Time frame: Up to 2 months
HDL-cholesterol
Time frame: Up to 2 months
Total Cholesterol
Time frame: Up to 2 months
Triglycerides
Time frame: Up to 2 months
Glucose
Time frame: Up to 2 months
Uric acid
Time frame: Up to 2 months
Systemic blood pressure
Time frame: Up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defatted flaxseed flour, Golden flaxseed flour and Whole brown flaxseed flour in people with Adult Women and Overweight, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2012.