Nutritional Intervention With Yogurt and Flaxseed in Women With Profiles Lipi

Overweight Clinical Trial

— flaxseed  

Official title:

Nutritional Intervention With Yogurt and Flaxseed in Women With Profiles Lipidic to the Limit: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047123
• Other study ID #: Elena García-García 2
• Secondary ID: Enrique Roche Co
• Status: Completed
• Phase: N/A
• First received: January 24, 2014
• Last updated: July 19, 2014
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2014
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• voluntarily participation

• ages between 25-70 years

• undergoing dislipidemia

• with no pharmacological treatment

• cholesterol (250-300 mg/dL)

• triglycerides (160-175 mg/dL)

Exclusion Criteria:

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight

Intervention

Dietary Supplement:
• Raw Flaxseed
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.

Locations

Country	Name	City	State
Spain	Pharmacy Iborra Campos	Elche	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days	Yes