Overweight
Conditions
Keywords
breakfast cereal, omega-3, cholesterol, lipidic profile, consumption, acceptability
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.
Interventions
DIETARY_SUPPLEMENTCereals
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.
Sponsors
Instituto de Salud Carlos III
Universidad Miguel Hernandez de Elche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem. | 30 days | Circulating parameters of cholesterol total |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight (Kg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem. | 30 days | In this table the investigators present the weight of the three intervented groups |
| Hip/waist measure (cm) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem. | 30 days | In this table the investigators present the hip / waist measure of the three intervented groups |
| Cholesterol HDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem. | 30 days | Circulating parameters of cholesterol HDL |
| Cholesterol LDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem. | 30 days | Circulating parameters of cholesterol LDL |
| Triglycerides characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem. | 30 days | Circulating parameters of triglycerides |
| Glucose characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem. | 30 days | Circulating parameters of glucose |
| BMI (Kg/m2) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem. | 30 days | In this table the investigators present the BMI of the three intervented groups |
| Systolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem. | 30 days | In this table the investigators present the systolic pressure of the three intervented groups |
| Diastolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem. | 30 days | In this table the investigators present the diastolic pressure of the three intervented groups |
Countries
Spain
Outcome results
None listed