Nutritional Intervention With Yogurt and Flaxseed in Women With Profiles Lipi

NCT02047123 | Completed DMC

• 2 other identifiers: Elena García-García 2Enrique Roche Collado
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight

Keywords

commercial flaxseed; cholesterol; lipidic profile; yoghurt; consumption

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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).

Dietary Supplement: Raw Flaxseed

Interventions

Raw Flaxseed 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.

Also known as: Raw Flaxseed "Lino Dorado" 8426904171561

Raw Flaxseed

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• voluntarily participation
• ages between 25-70 years
• undergoing dislipidemia
• with no pharmacological treatment
• cholesterol (250-300 mg/dL)
• triglycerides (160-175 mg/dL)

You may not qualify if:

• subjects undergoing any pharmacological treatment that may influence lipid metabolism
• subjects that were deemed to be unlikely to complete the treatment or to cooperate fully at the investigator´s discretion.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Pharmacy Iborra Campos

Elche, Alicante, 03202, Spain

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elena García, PDI

  Universidad Miguel Hernandez de Elche

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PID

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: November 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

ES (1)