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Completed

NCT Number: NCT02193659

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pharmacy Iborra Campos

Elche, Alicante, 03202, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cereals

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.

Other names: Papilla multicereales con Omega-3 0628413, Papilla multicereales 0528413

Primary outcomes

  1. Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.

    Time frame: 30 days

    Circulating parameters of cholesterol total

Secondary outcomes

  1. Weight (Kg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.

    Time frame: 30 days

    In this table the investigators present the weight of the three intervented groups

  2. Cholesterol HDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.

    Time frame: 30 days

    Circulating parameters of cholesterol HDL

  3. Cholesterol LDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.

    Time frame: 30 days

    Circulating parameters of cholesterol LDL

  4. Triglycerides characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.

    Time frame: 30 days

    Circulating parameters of triglycerides

  5. Glucose characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.

    Time frame: 30 days

    Circulating parameters of glucose

  6. BMI (Kg/m2) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.

    Time frame: 30 days

    In this table the investigators present the BMI of the three intervented groups

  7. Hip/waist measure (cm) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.

    Time frame: 30 days

    In this table the investigators present the hip / waist measure of the three intervented groups

  8. Systolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.

    Time frame: 30 days

    In this table the investigators present the systolic pressure of the three intervented groups

  9. Diastolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.

    Time frame: 30 days

    In this table the investigators present the diastolic pressure of the three intervented groups

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: cereals

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jul 17, 2014
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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