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

Miguel Hernández University of Elche

Status: Completed

Conditions: Overweight

Treatments: Dietary Supplement: Cereals

Study type: Interventional

Funder types: Other

Identifiers

NCT02193659

Enrique Roche Collado (Other Grant/Funding Number)

Elena García-García 3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: Female

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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96 participants in 1 patient group

Cereals

Experimental group

Description:

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. The energy intake of the designed diet was similar into the three groups (ranging 1900-2000 Kcal per day).

Treatment:

Dietary Supplement: Cereals