Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile (cereals)
Primary Purpose
Overweight
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cereals
Sponsored by

About this trial
This is an interventional prevention trial for Overweight focused on measuring breakfast cereal, omega-3, cholesterol, lipidic profile, consumption, acceptability
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.
Sites / Locations
- Pharmacy Iborra Campos
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cereals
Arm 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).
Outcomes
Primary Outcome Measures
Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Circulating parameters of cholesterol total
Secondary Outcome Measures
Weight (Kg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
In this table the investigators present the weight 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.
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.
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.
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.
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.
In this table the investigators present the BMI 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.
In this table the investigators present the hip / waist measure 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.
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.
In this table the investigators present the diastolic pressure of the three intervented groups
Full Information
NCT ID
NCT02193659
First Posted
February 23, 2014
Last Updated
August 24, 2015
Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT02193659
Brief Title
Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile
Acronym
cereals
Official Title
Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile: a Randomized Simple Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Instituto de Salud Carlos III
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
breakfast cereal, omega-3, cholesterol, lipidic profile, consumption, acceptability
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cereals
Arm Type
Experimental
Arm 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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Cereals
Other Intervention Name(s)
Papilla multicereales con Omega-3 0628413, Papilla multicereales 0528413
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Description
Circulating parameters of cholesterol total
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Weight (Kg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Description
In this table the investigators present the weight of the three intervented groups
Time Frame
30 days
Title
Cholesterol HDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Description
Circulating parameters of cholesterol HDL
Time Frame
30 days
Title
Cholesterol LDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Description
Circulating parameters of cholesterol LDL
Time Frame
30 days
Title
Triglycerides characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Description
Circulating parameters of triglycerides
Time Frame
30 days
Title
Glucose characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Description
Circulating parameters of glucose
Time Frame
30 days
Title
BMI (Kg/m2) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Description
In this table the investigators present the BMI of the three intervented groups
Time Frame
30 days
Title
Hip/waist measure (cm) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Description
In this table the investigators present the hip / waist measure of the three intervented groups
Time Frame
30 days
Title
Systolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Description
In this table the investigators present the systolic pressure of the three intervented groups
Time Frame
30 days
Title
Diastolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Description
In this table the investigators present the diastolic pressure of the three intervented groups
Time Frame
30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena García-García, PDI
Organizational Affiliation
Universidad Miguel Hernandez de Elche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pharmacy Iborra Campos
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile
We'll reach out to this number within 24 hrs