NCT02193659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

February 23, 2014

Last Update Submit

August 24, 2015

Conditions

Overweight

Keywords

breakfast cerealomega-3cholesterollipidic profileconsumptionacceptability

Outcome Measures

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.

    Circulating parameters of cholesterol total

    30 days

Secondary Outcomes (9)

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

    30 days

  • 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

  • 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

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

    30 days

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

    30 days

  • +4 more secondary outcomes

Study Arms (1)

Cereals

EXPERIMENTAL

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).

Dietary Supplement: Cereals

Interventions

CerealsDIETARY_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.

Also known as: Papilla multicereales con Omega-3 0628413, Papilla multicereales 0528413
Cereals

Eligibility Criteria

Age25 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • voluntarily participation
  • ages between 25-70 years
  • undergoing dyslipidemia
  • with no pharmacological treatment
  • cholesterol (250-300 mg/dL)
  • triglycerides (160-175 mg/dL)

You may not qualify if:

  • subjects undergoing any pharmacological treatment that may influence lipid metabolism
  • subjects that were deemed to be unlikely to complete the treatment or to cooperate fully at the investigator´s discretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmacy Iborra Campos

Elche, Alicante, 03202, Spain

Location

MeSH Terms

Conditions

Overweight

Interventions

Edible Grain

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crops, AgriculturalFoodDiet, Food, and NutritionPhysiological PhenomenaSeedsFood and Beverages

Study Officials

  • Elena García-García, PDI

    Universidad Miguel Hernandez de Elche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, PID

Study Record Dates

First Submitted

February 23, 2014

First Posted

July 17, 2014

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

ES(1)