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

Study Overview
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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.

Official Title
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Effect of Hipoernergetic Diet Combined or Not With Coconut Flour on Overweight Women

Conditions
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Obesity, Cardiovascular Risk Factor

Intervention / Treatment
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* Dietary Supplement: Coconut flour
* Behavioral: Diet


Participation Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Supplement: Coconut flour<br>Diet hipoernergetic plus 26g/day coconut flour during three months (12weeks). | Dietary Supplement: Coconut flour<br>* Patients 9 months following treatment, starting at 3 months with diet hipoenergetica 3 months washout and sixth month diet hiponergetic more coconut flour.<br>|
| Active Comparator: Nutritional Treatment<br>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 | Behavioral: Diet<br>* Patients were instructed to follow the dietary treatment for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometry | To evaluate the effect to coconut flour in the improvement of weight, waist circumference and neck circumference in voluntary overweight and obesity | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | To evaluate the effect the coconut flour in lowering total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol. | 9 months | 
| Quality of the diet | To evaluating the effect of treatment on the nutritional quality of the diet | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Coconut flour, Diet quality, Cardiovascular risk factor