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

Not Applicable

Completed

• Conditions: Obesity; Cardiovascular Risk Factor
• Interventions: Dietary Supplement: Coconut flour; Behavioral: Diet

• Registration Number: NCT02152111
• Lead Sponsor: Universidade Federal do Rio de Janeiro

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-05-28
• Status Verified: 2014-06
• Study First Posted: 2014-06-02
• Last Update Submitted: 2014-06-22
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary Supplement: Coconut flour	Coconut flour	Diet hipoernergetic plus 26g/day coconut flour during three months (12weeks).
Nutritional Treatment	Diet	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

Primary Outcome Measures

Name	Time	Method
Anthropometry	9 months	To evaluate the effect to coconut flour in the improvement of weight, waist circumference and neck circumference in voluntary overweight and obesity

Secondary Outcome Measures

Name	Time	Method
Lipid profile	9 months	To evaluate the effect the coconut flour in lowering total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol.
Quality of the diet	9 months	To evaluating the effect of treatment on the nutritional quality of the diet