Hipoenergetic Effect of Diet Associated or Not With the Consumption of Coconut Flour in Women With Overweight

NCT ID: NCT02152111

Last Updated: 2014-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-03-31

Brief Summary

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This study aimed to evaluate the effect of weight loss with diet combined coconut flour consumption improvement weight loss and reduction in glucose, cholesterol in obese women.

Detailed Description

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This is a clinical trial with two groups, one receiving hipoenergetic diet for 180 days and another group with hipoenergetic diet for 90 days, a washout period for another 90 days and another period for another 90 days diet meal plus hipoenergética coconut. In order to assess body mass, waist circumference and neck, assess the lipid profile, glucose and uric acid.

Conditions

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Obesity Cardiovascular Risk Factor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dietary Supplement: Coconut flour

Diet hipoernergetic plus 26g/day coconut flour during three months (12weeks).

Group Type EXPERIMENTAL

Coconut flour

Intervention Type DIETARY_SUPPLEMENT

Patients 9 months following treatment, starting at 3 months with diet hipoenergetica 3 months washout and sixth month diet hiponergetic more coconut flour.

Nutritional Treatment

All patients received an individualized diet plan and balanced. The diet was calculated 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 total energy value

Group Type ACTIVE_COMPARATOR

Diet

Intervention Type BEHAVIORAL

Patients were instructed to follow the dietary treatment for 6 months.

Interventions

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Coconut flour

Patients 9 months following treatment, starting at 3 months with diet hipoenergetica 3 months washout and sixth month diet hiponergetic more coconut flour.

Intervention Type DIETARY_SUPPLEMENT

Diet

Patients were instructed to follow the dietary treatment for 6 months.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

women \> 20 years old BMI \>25 Kg/m²

Exclusion Criteria

Performing diets and / or making use of drugs for the reduction of body weight; Supplements of any kind; Pregnant and lactating women; In use of statins; With voluntary water restriction. -
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth de Paula Franco

Miss

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth P Franco, Nutricionist

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Other Identifiers

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05155812.2.0000.5257

Identifier Type: -

Identifier Source: org_study_id

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