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Nutritional Intervention With Yogurt and Flaxseed in Women With Profiles Lipi (flaxseed)

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Raw Flaxseed
Sponsored by
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring commercial flaxseed, cholesterol, lipidic profile, yoghurt, consumption

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Pharmacy Iborra Campos

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Raw Flaxseed

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 24, 2014
Last Updated
July 19, 2014
Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT02047123
Brief Title
Nutritional Intervention With Yogurt and Flaxseed in Women With Profiles Lipi
Acronym
flaxseed
Official Title
Nutritional Intervention With Yogurt and Flaxseed in Women With Profiles Lipidic to the Limit: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
commercial flaxseed, cholesterol, lipidic profile, yoghurt, consumption

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raw Flaxseed
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Raw Flaxseed
Other Intervention Name(s)
Raw Flaxseed "Lino Dorado" 8426904171561
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anthropometric characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Description
In this table we present five parameters of the three intervented groups
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena García, PDI
Organizational Affiliation
Universidad Miguel Hernandez de Elche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pharmacy Iborra Campos
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain

12. IPD Sharing Statement

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Nutritional Intervention With Yogurt and Flaxseed in Women With Profiles Lipi

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