NCT01962844

Brief Summary

The purpose of this study is to evaluate the supplementation with extra virgin of coconut oil combined with a nutritional counseling in reducing anthropometry and improves the lipid profile in patients with chronic coronary disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 14, 2013

Status Verified

October 1, 2013

Enrollment Period

2.2 years

First QC Date

October 8, 2013

Last Update Submit

October 10, 2013

Conditions

Keywords

chronic coronary artery diseasecoconut oil extra virginindex of diet qualitynutritional treatment

Outcome Measures

Primary Outcomes (1)

  • Anthropometry

    To evaluate the effect of extra virgin coconut oil in the improvement of weight, waist circumference and neck circumference in patients with chronic coronary artery disease

    3 months

Secondary Outcomes (2)

  • Lipid profile

    3 months

  • Quality of the diet

    3 months

Study Arms (2)

Nutritional treatment

OTHER

All patients received an individualized diet plan and balanced. The diet was calculated according to the nutritional status and the protein 15-20% of total energy value, lipids 25-30% of daily energy intake and carbohydrate 50-60% of of total energy value

Behavioral: Diet

extra virgim coconut oil group

EXPERIMENTAL

Oil from coconuts (cocos nucifera L.) contains a high proportion of medium chain fatty acids, principally the lauric acid (12:0), in proportions that range from 45 to 50%

Dietary Supplement: Coconut Oil

Interventions

Coconut OilDIETARY_SUPPLEMENT

Patients were followed for 6 months with dietary treatment. Beginning supplementation with coconut oil extra virgin from the third month of intervention nutrition. Coconut oil was consumed neat or added to fruit.

Also known as: coconut oil, palm grease, palmoil
extra virgim coconut oil group
DietBEHAVIORAL

Patients were instructed to follow the dietary treatment for 6 months

Also known as: dietary advice
Nutritional treatment

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presenting chronic coronary artery disease (myocardial infarction and/or stable angina

You may not qualify if:

  • angioplasty and/or coronary artery bypass grafting and previous cardiovascular event \<6 months and those who had chronic renal failure with creatinine values\> the 2mg/dl and liver disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional do Coração

Rio de Janeiro, Rio de Janeiro, 22240-002, Brazil

Location

MeSH Terms

Interventions

Coconut OilDietNutrition Assessment

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsPlant OilsOilsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Diuli A Cardoso, Ms

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher official

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 14, 2013

Study Start

January 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

October 14, 2013

Record last verified: 2013-10

Locations