Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile

Overweight Clinical Trial

— cereals  

Official title:

Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile: a Randomized Simple Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193659
• Other study ID #: Elena García-García 3
• Secondary ID: Enrique Roche Co
• Status: Completed
• Phase: N/A
• First received: February 23, 2014
• Last updated: August 24, 2015
• Start date: September 2013
• Est. completion date: January 2014

Study information

• Verified date: August 2015
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The inclusion of breakfast cereals enriched with omega-3 for female users of a pharmacy who had some lipidic profiles to the limit is highly conditioned by their nutritional acceptance. The main objective is to assess the effect of breakfast cereals intake with omega-3 on women lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce the small dyslipidemia.

Description:

The investigators performed an intervention including 133 women (age 25-70 years). Participants were randomly and single-blind distributed into three groups: Group 1 (n=38) consumed cereal with omega-3 (Cw-3 + D), cereal (C) and diet (D), Group 2 (n=38). Volunteers consumed (C) + (D) and Group 3 (n=37) consumed only diet. All groups followed a limit levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and glucose were determined at the beginning and end of a 30-day test.

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: 96
• Est. completion date: January 2014
• Est. primary completion date: December 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 dyslipidemia

• 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:
• Cereals
The participants were randomly single blind controlled trial distributed into three groups: (1, n =38), (2, n =38), (3, n =37). For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals 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	Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.	Circulating parameters of cholesterol total	30 days	Yes
Secondary	Weight (Kg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.	In this table the investigators present the weight of the three intervented groups	30 days	Yes
Secondary	Cholesterol HDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.	Circulating parameters of cholesterol HDL	30 days	Yes
Secondary	Cholesterol LDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.	Circulating parameters of cholesterol LDL	30 days	Yes
Secondary	Triglycerides characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.	Circulating parameters of triglycerides	30 days	Yes
Secondary	Glucose characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.	Circulating parameters of glucose	30 days	Yes
Secondary	BMI (Kg/m2) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.	In this table the investigators present the BMI of the three intervented groups	30 days	Yes
Secondary	Hip/waist measure (cm) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.	In this table the investigators present the hip / waist measure of the three intervented groups	30 days	Yes
Secondary	Systolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.	In this table the investigators present the systolic pressure of the three intervented groups	30 days	Yes
Secondary	Diastolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.	In this table the investigators present the diastolic pressure of the three intervented groups	30 days	Yes