Clinical trial NCT02193659: Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile
Official title: Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile: a Randomized Simple Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: breakfast cereal
omega-3
cholesterol
lipidic profile
consumption
acceptability
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2014-07-17
Enrollment: 96
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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)

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.

Primary outcomes:
measure: Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
timeFrame: 30 days
Secondary outcomes:
measure: Weight (Kg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
timeFrame: 30 days
measure: Cholesterol HDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
timeFrame: 30 days
measure: Cholesterol LDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
timeFrame: 30 days
measure: Triglycerides characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
timeFrame: 30 days
measure: Glucose characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
timeFrame: 30 days
measure: BMI (Kg/m2) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
timeFrame: 30 days
measure: Hip/waist measure (cm) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
timeFrame: 30 days
measure: Systolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
timeFrame: 30 days
measure: Diastolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
timeFrame: 30 days
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Pharmacy Iborra Campos
state: Alicante
Study officials:
affiliation: Universidad Miguel Hernandez de Elche
name: Elena García-García, PDI
role: PRINCIPAL_INVESTIGATOR
References: