OverweightflaxseedNCT02047123
Nutritional Intervention With Yogurt and Flaxseed in Women With Profiles Lipi
A study testing Raw Flaxseed in people with Overweight, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
Flax (Linum usitatissimum L.) is an economically important oilseed. Lifestyle and diet are the first line interventions to reduce the short-term and long-term cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Overweight
- What is being tested?
- Raw Flaxseed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2012to Apr 2013
- 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 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- voluntarily participation
- ages between 25-70 years
- undergoing dislipidemia
- with no pharmacological treatment
- cholesterol (250-300 mg/dL)
- triglycerides (160-175 mg/dL)
Who cannot join
- subjects undergoing any pharmacological treatment that may influence lipid metabolism
- lipid levels outside the range of those specified in the inclusion criteria
- subjects that were deemed to be unlikely to complete the treatment or to cooperate fully at the investigator´s discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Intervention With Yogurt and Flaxseed in Women With Profiles Lipidic to the Limit: A Randomized Controlled Trial
Flax (Linum usitatissimum L.) is an economically important oilseed. Lifestyle and diet are the first line interventions to reduce the short-term and long-term cardiovascular risk factors. Due to its high content of lignans, α-linolenic acid (LNA) and fiber, flaxseed has a beneficial effect on CVD risk factors, components to decrease the risk of cardiovascular disease. Objective: To determine the effect of the consumption of flax seed yogurt on the women lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce the small dyslipidemia. The investigators performed an intervention including 133 women (age= 25-70 years). Participants were randomly and double-blind distributed into three groups: Group 1 (n= 30) consumed flaxseed (FS), yoghurt (Y) and diet (D), Group 2 (n= 32) volunteers consumed (Y) + (D) and Group 3 (n=27) consumed only diet. All groups followed a limit levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides and were determined at the beginning and end of a 30-day test. As a result, group 1 presented significantly reduced total cholesterol levels. Correlation analysis indicated that the intake of (FS) could explain the flaxseed effect of the variation of the cholesterol and TG in this group. Altogether, this study concludes that consumption FS exert a positive impact in total cholesterol level and TG
Read the detailed description
It is an analytical intervention study, using a random single blind controlled type trial, conducted at a pharmacy in Elche on female clients with mild alterations in their lipid profile. Since they were patients with a high cardiovascular risk, the investigators aimed to determine the effect of the administration of (FS+Y+D), (Y+D) and (D) on various nutritional indicators.
A monitoring of nutritional intervention was carried out for 30 days and blood samples were obtained by capillary puncture for total cholesterol levels, triglycerides, glucose. These parameters were determined in situ by dry chemistry. A series of anthropometric measures were also carried out at the beginning and at the end of the study including weight and height, BMI (Body Mass Index), WHR (waist-hip ratio), systolic and diastolic arterial pressure and heart rate.
Statistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint Technologies, Inc. Warrington, VA, USA); likewise, significance was defined at p ≤ 0.05. Data are reported as mean ± standard error of the mean (sem). Intra-group statistical comparisons were performed using the following hypothesis tests, both parametric and non-parametric: t-test, sign test and signed rank test for paired samples. Inter-group statistical comparisons were performed using the one-way analysis of variance and the Kruskal-Wallis hypothesis tests. Also, Fisher's least significant difference (LSD) Multiple Range Test and Tukey's honestly significant difference (HSD) were used in order to determine which means were significantly different from the others. In addition, Generalized Multiple Regression was used to statistically analyze the relationships between the variations in the lipid profile and the different factors included in the study.
- Conditions
- Overweight
- Being tested
- Raw Flaxseed
- Keywords
- commercial flaxseed, cholesterol, lipidic profile, yoghurt, consumption
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raw FlaxseedDietary supplement
Also called Raw Flaxseed "Lino Dorado" 8426904171561
The participants were randomly single blind controlled trial distributed into three groups: (1, n =30), (2, n =32), (3, n =27). For 30 days, participants in group 1 took with 15g flaxseed mixed with yoghurt and diet,(the 15g of flaxseed that was provided in addition to the linen package spoon so all would take far it) group 2 took yoghurt and diet, and group 3 only received the diet.
| Study group | Role | What they receive |
|---|---|---|
| Raw Flaxseed | Experimental | For 30 days, participants in group 1 took with 15g flaxseed mixed with yoghurt and diet,(the 15g of raw flaxseed that was provided in addition to the linen package spoon so all would take far it) group 2 took yoghurt and diet, and group 3 only received the diet.The energy intake of the designed diet was similar into the three groups (ranging 1900-2000 Kcal per day). Receives: Dietary Supplement: Raw Flaxseed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
In this table we present five parameters of the three intervented groups
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startNov 2012
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Elena García García, Universidad Miguel Hernandez de Elche
- Investigators
- Elena García, PDI, Principal investigator, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047123
- Sponsor's protocol ID
- Elena García-García 2
- Other IDs
- Enrique Roche Collado
- Acronym
- flaxseed
- Status last verified
- Jul 2014
- First submitted
- 24 Jan 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention With Yogurt and Flaxseed in Women With Profiles Lipidic to the Limit: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02047123
- Acronym / sponsor ID
- flaxseed / Elena García-García 2
- Conditions
- Overweight
- Keywords
- commercial flaxseed, cholesterol, lipidic profile, yoghurt, consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Jan 2014 (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.
Flax (Linum usitatissimum L.) is an economically important oilseed. Lifestyle and diet are the first line interventions to reduce the short-term and long-term cardiovascular risk factors. Due to its high content of lignans, α-linolenic acid (LNA) and fiber, flaxseed has a beneficial effect on CVD risk factors, components to decrease the risk of cardiovascular disease. Objective: To determine the effect of the consumption of flax seed yogurt on the women lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce the small dyslipidemia. The investigators performed an intervention including 133 women (age= 25-70 years). Participants were randomly and double-blind distributed into three groups: Group 1 (n= 30) consumed flaxseed (FS), yoghurt (Y) and diet (D), Group 2 (n= 32) volunteers consumed (Y) + (D) and Group 3 (n=27) consumed only diet. All groups followed a limit levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides and were determined at the beginning and end of a 30-day test. As a result, group 1 presented significantly reduced total cholesterol levels. Correlation analysis indicated that the intake of (FS) could explain the flaxseed effect of the variation of the cholesterol and TG in this group. Altogether, this study concludes that consumption FS exert a positive impact in total cholesterol level and TG
Detailed description
It is an analytical intervention study, using a random single blind controlled type trial, conducted at a pharmacy in Elche on female clients with mild alterations in their lipid profile. Since they were patients with a high cardiovascular risk, the investigators aimed to determine the effect of the administration of (FS+Y+D), (Y+D) and (D) on various nutritional indicators.
A monitoring of nutritional intervention was carried out for 30 days and blood samples were obtained by capillary puncture for total cholesterol levels, triglycerides, glucose. These parameters were determined in situ by dry chemistry. A series of anthropometric measures were also carried out at the beginning and at the end of the study including weight and height, BMI (Body Mass Index), WHR (waist-hip ratio), systolic and diastolic arterial pressure and heart rate.
Statistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint Technologies, Inc. Warrington, VA, USA); likewise, significance was defined at p ≤ 0.05. Data are reported as mean ± standard error of the mean (sem). Intra-group statistical comparisons were performed using the following hypothesis tests, both parametric and non-parametric: t-test, sign test and signed rank test for paired samples. Inter-group statistical comparisons were performed using the one-way analysis of variance and the Kruskal-Wallis hypothesis tests. Also, Fisher's least significant difference (LSD) Multiple Range Test and Tukey's honestly significant difference (HSD) were used in order to determine which means were significantly different from the others. In addition, Generalized Multiple Regression was used to statistically analyze the relationships between the variations in the lipid profile and the different factors included in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raw Flaxseed | Experimental | Dietary Supplement: Raw FlaxseedFor 30 days, participants in group 1 took with 15g flaxseed mixed with yoghurt and diet,(the 15g of raw flaxseed that was provided in addition to the linen package spoon so all would take far it) group 2 took yoghurt and diet, and group 3 only received the diet.The energy intake of the designed diet was similar into the three groups (ranging 1900-2000 Kcal per day). |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- voluntarily participation
- ages between 25-70 years
- undergoing dislipidemia
- with no pharmacological treatment
- cholesterol (250-300 mg/dL)
Key exclusion criteria (3 listed)
- subjects undergoing any pharmacological treatment that may influence lipid metabolism
- lipid levels outside the range of those specified in the inclusion criteria
- subjects that were deemed to be unlikely to complete the treatment or to cooperate fully at the investigator´s discretion.
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 |
|---|---|---|
| Raw FlaxseedAlso: Raw Flaxseed "Lino Dorado" 8426904171561The participants were randomly single blind controlled trial distributed into three groups: (1, n =30), (2, n =32), (3, n =27). For 30 days, participants in group 1 took with 15g flaxseed mixed with yoghurt and diet,(the 15g of flaxseed that was provided in addition to the linen package spoon so all would take far it) group 2 took yoghurt and diet, and group 3 only received the diet. | Dietary supplement | Raw Flaxseed |
Primary outcome
Anthropometric characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Time frame: 30 days
In this table we present five parameters of the three intervented groups
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 22 Jul 2014.
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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.
Elena García, PDI principal investigator
Universidad Miguel Hernandez de Elche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raw Flaxseed in people with Overweight, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
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 6 inclusion and 3 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 22 Jul 2014. 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 Spain. 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?
Anthropometric characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem. (time frame: 30 days). 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 22 Jul 2014.