NCT02193659

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Universidad Miguel Hernandez de Elche · Academic / Other
• Sex: Female
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Overweight

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2014-07-17
• Last updated: 2015-08-26

Locations

1 site across 1 country: Spain