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

NCT ID: NCT02193659

Last Updated: 2015-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-01-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Cereals

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).

Group Type: EXPERIMENTAL

Cereals

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Papilla multicereales con Omega-3 0628413; Papilla multicereales 0528413

Eligibility Criteria

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)

• subjects that were deemed to be unlikely to complete the treatment or to cooperate fully at the investigator´s discretion.

Exclusion Criteria

• subjects undergoing any pharmacological treatment that may influence lipid metabolism

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: lead

Responsible Party

Elena García García

PhD, PID

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elena García-García, PDI

Role: PRINCIPAL_INVESTIGATOR

Universidad Miguel Hernandez de Elche

Locations

Pharmacy Iborra Campos

Elche, Alicante, Spain

Countries

Spain

Other Identifiers

Enrique Roche Collado

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Elena García-García 3

Identifier Type: -

Identifier Source: org_study_id