Nutritional Intervention With Yogurt and Flaxseed in Women With Profiles Lipi

NCT ID: NCT02047123

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-04-30

Brief 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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Raw Flaxseed

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).

Group Type: EXPERIMENTAL

Raw Flaxseed

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Raw Flaxseed "Lino Dorado" 8426904171561

Eligibility Criteria

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)

• subjects that were deemed to be unlikely to complete the treatment or to cooperate fully at the investigator´s discretion.

Exclusion Criteria

• subjects undergoing any pharmacological treatment that may influence lipid metabolism

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: lead

Responsible Party

Elena García García

PID

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elena García, PDI

Role: PRINCIPAL_INVESTIGATOR

Universidad Miguel Hernandez de Elche

Locations

Pharmacy Iborra Campos

Elche, Alicante, Spain

Countries

Spain

Other Identifiers

Enrique Roche Collado

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Elena García-García 2

Identifier Type: -

Identifier Source: org_study_id